Background:Mesalazine preparations serve as first-line therapy for active mild-to-moderate ulcerative colitis(UC),however,not all patients respond to mesalazine.Patients with mesalazine-refractory UC often switch to c...Background:Mesalazine preparations serve as first-line therapy for active mild-to-moderate ulcerative colitis(UC),however,not all patients respond to mesalazine.Patients with mesalazine-refractory UC often switch to corticosteroids,immunological therapy,and biological agents,but their use is limited owing to their well-characterised side effects(e.g.osteoporosis and cushingoid feature).Therefore,there is an unmet medical need for novel treatments with a manageable safety profile for patients with mesalazine-refractory UC.New Wumei Pill is a novel and effective herbal prescription for the treatment of UC,and our preliminary study suggested that New Wumei Pill has a significant effect on patients with mesalazine-refractory UC.However,its effectiveness and safety has not been evaluated convincingly.Objectives:This trail aims to evaluate efficacy,safety and mechanisms of New Wumei Pill in the treatment of patients with mesalazine-refractory UC.Methods:This is a prospective,randomized,double-blind control trial,in which 72 patients with mesalazine-refractory mild-to-moderate UC will be randomized in a 1:1 ratio in the treatment and control group.Patients will be screened for eligibility at the outpatient and ward of the Department of Gastroenterology in Dongfang Hospital,Beijing University of Chinese Medicine.72 participants will undergo strict screening to meet the diagnostic criteria of mildly to moderately active UC,with modified Mayo score of 3-10 points.All patients will be administered by mesalazine enteric-coated tablets for 8 weeks,at the same time,the patients in treatment group will receive New Wumei Pill,while patients from control group will be administered by dummy New Wumei Pill.Results:The primary outcomes are clinical efficacy rate and clinical remission rate according to the modified Mayo score.The secondary outcomes are individual symptom score,TCM syndrome score,endoscopic response rate,mucosal healing rate,and quality of life scale score.Finally,biological samples from participants will be preserved to reveal the mechanisms of New Wumei Pill on UC.Conclusions:We hypothesize that the patients with mesalazine-refractory mild-to-moderate UC will benefit from New Wumei Pill.If successful,this trial will provide evidence of traditional Chinese medicine in the treatment of UC,and hold promises for novel options UC patients and policymakers.展开更多
Introduction:With the incidence of chronic kidney disease(CKD)increasing year by year,it is particularly important to intervene in the early stage of CKD(stages 1–3).Unfortunately,the effective drug treatment methods...Introduction:With the incidence of chronic kidney disease(CKD)increasing year by year,it is particularly important to intervene in the early stage of CKD(stages 1–3).Unfortunately,the effective drug treatment methods for CKD(stages 1–3)are lacking.Guben Tongluo Formula(GTF)is the experience formula of Professor Liqun He,a famous traditional Chinese medicine(TCM)doctor in Shanghai.Our previous studies demonstrated that GTF might effectively alleviate CKD via multi-mechanisms.As the first angiotensin-2 receptor antagonist for treating hypertension,losartan potassium(LP)could effectively reduce blood pressure,decrease cardiovascular risk,and delay the occurrence of end-stage renal disease.Thus,we design this clinical protocol of GTF combining LP to observe the efficacy and safety of GTF and try to provide a novel drug treatment method for treating CKD(stages 1–3)patients.Methods and analysis:This is a multicenter randomized controlled clinical trial.160 participants will be enrolled in this trial and divided into LP group,GTF group,LP+GTF group,and placebo group randomly assigning 1:1:1:1 principle.LP group will receive general treatments combining LP,GTF group will receive general treatments combining GTF,and the GTF+LP group will receive general treatments combining GTF and LP.Placebo group will receive general treatments combining placebo treatment.The primary evaluation index will be the change of serum creatinine after treatment.Secondary evaluation indexes include changes in blood urea nitrogen,serum uric acid,estimated glomerular filtration rate,etc.;immune indicators and renal fibrosis indicators,as well as TCM symptoms.Besides,vital sign indicators and adverse events will be closely observed.Ethics and dissemination:The protocol has been approved by the Ethics Committee of Seventh People’s Hospital of Shanghai University of Traditional Chinese Medicine(reference number:2024-7th-HIRB-094)and other ethics committees at each center.With the implementation of this clinical trial,it would offer a TCM formula for the treatment of CKD(stages 1–3)and clarify the underlying mechanism of GTF for alleviating CKD.Trial registration:This trial is registered with ChiCTR2400090125 and registered on September 24,2024.展开更多
BACKGROUND： Rheumatoid arthritis（RA） is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, until now Western acupuncture studies on RA have not sho...BACKGROUND： Rheumatoid arthritis（RA） is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, until now Western acupuncture studies on RA have not shown conclusive positive results. Acupuncture is regarded as a reflex therapy that has effects on the human autonomic nervous system. By establishing a traditional Chinese medicine（TCM） diagnosis first, the practitioner is able to choose acupoints according to the state of each individual patient.METHODS/DESIGN： We are interested if acupuncture, using a classical diagnostic procedure to allocate acupoints to the patient according to the Shang Han Lun theory, can be effective in relieving pain, improving hand function and increasing health-related quality of life in RA.The authors intend to harmonize TCM diagnosis according to clinical and genetic profiles. Patients with the TCM diagnosis of a so-called Turning Point syndrome will be followed up in a randomized, prospective, double-blind, placebo-controlled, multicenter and three-armed parallel-group study with a standardized treatment in order to optimize potential therapeutic effects of acupuncture on pain, strength and muscle function of patients with RA as well as the influence on inflammation and quality of life.DISCUSSION： The findings of this study will provide important clinical information about the feasibility and efficacy of acupuncture treatment for RA patients. In addition, it will explore the feasibility of further acupuncture research.TRIAL REGISTRATION NUMBER： Clinical Trials.gov Identifier NCT02553005.展开更多
BACKGROUND： Chronic obstructive pulmonary disease （COPD） is a major public health problem worldwide. Pulmonary rehabilitation （PR） is an established intervention for the management of patients with COPD. Exercise...BACKGROUND： Chronic obstructive pulmonary disease （COPD） is a major public health problem worldwide. Pulmonary rehabilitation （PR） is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China. METHODS AND DESIGN： A multicenter, randomized, controlled trial will be conducted. A total of 464 patients meeting the inclusion criteria will be enrolled into this study with 232 patients in each of the trial group and the control group. Based on patient education, patients in the trial group will receive pulmonary Daoyin and continue with their usual therapy for three months. In the control group, patients will continue with their usual therapy. The primary outcome measures are exercise capacity assessed by the six-minute walking distance test and lung function. Secondary outcomes include dyspnea and quality of life. Measurements will be taken at baseline （month 0） and after the study period （month 3）. DISCUSSION： It is hypothesized that pulmonary Daoyin will have beneficial effects in improving exercise capacity and psychosocial function of patients with stable COPD, and will provide an alternative form of exercise training that is accessible for the large number of people with COPD. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is NCT01482000.展开更多
Objective:National Health Commission of the People's Republic of China collaborated with many ministries and commissions government and initiated a population-based cancer screening program in high-risk area of ru...Objective:National Health Commission of the People's Republic of China collaborated with many ministries and commissions government and initiated a population-based cancer screening program in high-risk area of rural China,targeting three types of cancer that are most prevalent in these areas,including esophageal,stomach and liver cancer.This study protocol was reported to show the design and evaluate the effectiveness of cancer screening and appropriate screening strategies of three cancers in rural China.Methods and analysis:A two-step design with cancer risk assessment based on questionnaire interview,Hepatitis B surface antigen(HBsAg)test strip and subsequent clinical intervention for high-risk populations was adopted&ee of charge at the local hospitals designated in the program.Ethic and dissemination:This study was approved by the Institutional Review Board of Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College.The results will evaluate the effectiveness of cancer screening and appropriate screening strategies in rural China.展开更多
Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promisin...Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.展开更多
BACKGROUND： Postoperative gastrointestinal dysfunction（PGD） is one of the most common complications following major surgeries under general anesthesia（GA）. Despite ongoing research and new drug treatments, abdomi...BACKGROUND： Postoperative gastrointestinal dysfunction（PGD） is one of the most common complications following major surgeries under general anesthesia（GA）. Despite ongoing research and new drug treatments, abdominal distension within 24 h postoperatively occurs in 8%–28% of all surgeries. We aim to analyze the effectiveness of preventing PGD by preoperatively stimulating Neiguan（PC6）, Zusanli（ST36） and Shangjuxu（ST37） bilaterally twice a day compared with sham-acupuncture treatment and standard treatment.METHODS AND DESIGN： This is a single-center, prospective practical randomized controlled trial. All groups will be given standard treatments. Patients undergoing vascular surgery under GA will be included from the Vascular Surgery Unit in West China Hospital of Sichuan University, China, and divided into three groups. The experimental group will receive routine treatments and acupuncture at PC6, ST36 and ST37 bilaterally with electrical stimulation twice a day for 20 min preoperatively. The sham-acupuncture group will receive pseudo-electroacupuncture at sham acupoints of PC6, ST36 and ST37, which are 1 cun away from the real acupoints. The routine-treatment group will not receive electroacupuncture. The outcomes include the incidence of abdominal distention, abdominal circumference, the degree of abdominal distension, the fi rst time of fl atus and defecation, and hospitalization duration. DISCUSSION： The results from this study will demonstrate whether preoperative electroacupuncture is an effective method for the prevention of PGD in patients undergoing vascular surgery under GA. This study may also provide a standardized acupuncture treatment for reduction of PGD. TRIAL REGISTRATION： This study is registered with the Chinese Clinical Trial Registry： Chi CTR-TRC-13003649.展开更多
BACKGROUND： Despite a recent American Heart Association （AHA） consensus statement emphasizing the importance of resistant hypertension （RH）, its control is still a challenge for conventional medicine. The Chinese...BACKGROUND： Despite a recent American Heart Association （AHA） consensus statement emphasizing the importance of resistant hypertension （RH）, its control is still a challenge for conventional medicine. The Chinese herbal formula, Qutan Huayu Fang, has been used effectively to assist antihypertensive agents in blood pressure control, but its effect for RH patients is still unclear. This pilot study aims to explore the effects of taking the formula in addition to antihypertensive medication in the management of RH. METHODS/DESIGN： A prospective cohort study will be conducted in two first-class hospitals of traditional Chinese medicine （TCM）. Eligible RH patients will be classified as the experimental group （n = 100） and the control group （n = 100） based on the interventions they receive. Participants taking antihypertensive agents and the Chinese herbal formula will be in the experimental group and those taking antihypertensive agents alone will be in the control group. The whole study will last 24 weeks, including an 8-week observation and follow-up at 24 weeks. The primary outcomes, assessed against patient baseline conditions, will be the reduction of systolic blood pressure and diastolic blood pressure as well as changes in TCM symptoms and signs. These outcomes will be assessed at weeks 2, 4, 6, and 8. The reductions of blood pressure will also be assessed at week 24. Cardiac events and mortality rate will be secondary outcomes and will be assessed at weeks 8 and 24. Any adverse reactions will be recorded during the study. The causal inference method will be used to assess the effectiveness of the inclusion of TCM herbal medicine in the management of patients with RH. DISCUSSION： This study will determine whether the Chinese herbal formula is helpful for RH patients treated with antihypertensive agents and the findings will provide a basis for further confirmatory studies TRIAL REGISTRATION NUMBER： ClinicalTria/s.gov Identifier NCT01904695展开更多
Radical mastectomy may lead to suppression of cellular immune function in patients with malignant tumors,and affect the quality of life(QOL)of patients.Immune suppression is a common cause of complications and adverse...Radical mastectomy may lead to suppression of cellular immune function in patients with malignant tumors,and affect the quality of life(QOL)of patients.Immune suppression is a common cause of complications and adverse reactions in adjuvant therapy after radical mastectomy of breast cancer.Currently,there are few proven effective treatments for immune suppression.Therefore,it’s necessary to develop a new treatment method.Press needle is widely used in clinical practice.However,there have been relatively few studies that evaluate the effects of press needle on postoperative immune function.The aim of the present study is to assess the effects of press needle on immune function and QOL in female breast cancer patients undergoing radical mastectomy.This study will be a single-center,randomized and single-blinded trial.Totally 78 eligible patients will be randomized in a ratio of 1:1 to the press needle group or the sham press needle group.During the treatment phase,patients will undergo five times weekly of verum press needle or sham press needle for 2 weeks.The primary outcome measures will be the peripheral blood levels of CD8^(+),CD4^(+),CD3^(+),and CD4^(+)/CD8^(+)T cells.The secondary outcome measures will be the changes of patients’QOL,evaluated by the Karnofsky Performance Scale score and the EORTC core quality of life questionnaire(EORTC QLQ-C30).Furthermore,5-year survival rate and recurrence rate will be evaluated.Safety and adverse events will be assessed at each visit.The results of this on-going study will provide clinical evidence for the effects and safety of press needle on immune function and QOL in patients after breast cancer resection compared with sham press needle.展开更多
Acupuncture has been widely used as an alternative and complementary therapy for premature ovarian insufficiency(POI)in China.However,research to date has not shown that acupuncture is effective for POI compared with ...Acupuncture has been widely used as an alternative and complementary therapy for premature ovarian insufficiency(POI)in China.However,research to date has not shown that acupuncture is effective for POI compared with hormone replacement therapy(HRT).We will conduct a randomized,controlled,and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on POI.Seventy-six patients with POI will be randomly assigned to two groups.The treatment group will receive twenty-eight one-hour sessions of acupuncture treatments,and the control group will receive 12-week HRT.The whole study will consist of a 12-week treatment plan and a 12-week follow-up session.The primary outcome is measured by changes in serum anti-Müllerian hormone and follicle-stimulating hormone(FSH)levels at weeks 12 and 24.Secondary outcome measures include estradiol,luteinizing hormone(LH),LH/FSH ratio,Kupperman index,and menstrual condition.This trial is expected to clarify whether or not acupuncture is effective and safe for POI compared with HRT.展开更多
Background: The Xingnao Kaiqiao acupuncture method, founded by Academician ShiXuemin, has outstanding efficacy in the treatment of ischemic stroke and has been widelyused at home and abroad. However, after half a cent...Background: The Xingnao Kaiqiao acupuncture method, founded by Academician ShiXuemin, has outstanding efficacy in the treatment of ischemic stroke and has been widelyused at home and abroad. However, after half a century of animal experiments and clinicalstudies, clearly and intuitively revealing its therapeutic mechanism is still a great challengefor researchers. Therefore, this experiment is based on the combination of medicine andengineering to study the immediate effects of the acupuncture method in treating patientsby recording the electroencephalography (EEG) activities of subjects during the acupunctureprocess and to further reveal the therapeutic mechanism at the brain level. Methods: Thistrial is an exploratory, prospective, single-arm interventional study involving a total ofpatients with ischemic stroke. Physicians will record EEG data from patients duringacupuncture as the primary outcome indicator. After pre-processing the EEG data,researchers will use various methods to analyze the immediate effects of acupuncture toobtain brain effectiveness. Deep learning will then be used to identify acupoint stimuli andreceive correspondence between the acupuncture effect and the brain’s internal state.National Institutes of Health Stroke Scale score before and after the acupuncture process willbe used as the secondary outcome indicator. Conclusion: This is the first study protocol toapply dynamic changes in EEG to explore a range of mechanisms of action of acupuncture inthe treatment of ischemic stroke. We propose a method to analyze EEG signals ofacupuncture patients. The deep learning model will be applied for supervised training toobtain the compelling relationship between the acupuncture method and internal brainstates, providing a new prospect for the digitization of traditional Chinese medicine.展开更多
Background： Vulvodynia, or vulvar pain, is a common condition in women; however, there are few evidence-based clinical trials evaluating nonpharmacological therapies for this condition. Acupuncture is one complementa...Background： Vulvodynia, or vulvar pain, is a common condition in women; however, there are few evidence-based clinical trials evaluating nonpharmacological therapies for this condition. Acupuncture is one complementary and integrative medicine therapy used by some patients with vulvodynia. This study evaluates two different acupuncture strategies for the treatment of vulvodynia and aims to evalu- ate whether either of the acupuncture protocols reduces vulvar pain, pain duration or pain with inter- course. The study also examines how long the effect of acupuncture lasts in women with vulvodynia. Methods/design： The study is designed as a randomized controlled trial, focused on two acupuncture protocols. Fifty-one patients who have had vulvodynia for more than 3 months will be recruited. Among them, 34 patients will be randomized into Groups la and 1b; those who are unwilling to receive acupuncture will be recruited into the standard care group （Group 2）. Patients in Group la will have acupuncture focused on the points in the pudendal nerve distribution area, while patients in Group lb will receive acupuncture focused on traditional （distal） meridian points. Patients in Group 2 will receive routine conventional treatments, such as using pain medications, local injections and physical therapies or other nonsurgical procedures. Acupuncture will last 45 min per session, once or twice a week for 6 weeks. The primary outcome measurement will be objective pain intensity, using the cotton swab test. The secondary outcome measurement will be subjective patient self-reported pain intensity, which will be conducted before cotton swab test. Pain intensities will be measured by an 11-point Numeric Pain Rating Scale. Pain duration and pain score during intercourse are recorded. Local muscle tension, tender- ness and trigger points （Ashi points） are also recorded. All measurements will be recorded at baseline （before the treatment）, at the end of each week during treatment and at the end of the 6weeks. Follow-up will be done 6 weeks following the last treatment. Discussion： Results of this trial will provide preliminary data on whether acupuncture provides better outcomes than nonacupuncture treatments, i.e., standard care, and whether acupuncture focused on the points in pudendal nerve distribution, near the pain area, has better results than traditional acupunc- ture focused on distal meridian points for vulvodynia.展开更多
Objective:The washing prescription for lower limb sprains(WPFLLS)has acceptable effects on chronic ankle sprains(CAS).To provide additional evidence supporting the efficacy of the WPFLLS prescription,we designed a mul...Objective:The washing prescription for lower limb sprains(WPFLLS)has acceptable effects on chronic ankle sprains(CAS).To provide additional evidence supporting the efficacy of the WPFLLS prescription,we designed a multicenter,double-blind,randomized controlled trial with professional ballet dancers who have a high incidence of chronic ankle sprain as the study subjects.Materials and methods:This is a multicenter,double-blind,randomized controlled trial.According to the strict inclusion and exclusion criteria,120 ballet dancers with CAS will be selected and randomly assigned to the traditional Chinese medicine(TCM)group or to the placebo group.Patients will be treated for 14 consecutive days and followed up for 28 days.The primary outcome is the ankle-hindfoot score of the American Orthopaedic Foot&Ankle Society(AOFAS).The secondary outcomes encompass the Visual Analog Scale(VAS),the Symptom Severity and Dance Performance Quality Index,and the frequency and dosage of externally applied rescue medication.Conclusions:This trial will provide high-quality clinical evidence on the efficacy and safety of WPFLLS in the treatment of CAS and provide clinical recommendations for subsequent studies on WPFLLS.展开更多
Objective:Acute ischemic stroke(AIS)is characterized by high morbidity and high mortality.In recent years,complementary and alternative medicine has gradually been widely accepted and applied.At present,traditional Ch...Objective:Acute ischemic stroke(AIS)is characterized by high morbidity and high mortality.In recent years,complementary and alternative medicine has gradually been widely accepted and applied.At present,traditional Chinese medicine therapy and standard treatments are used for the treatment of AIS.Xingnao-Jianshen prescriptions(XNJS)is an effective prescription for the clinical treatment of AIS,but there is a lack of large-scale clinical evidence to confirm its clinical efficacy.Therefore,our team designed this protocol to evaluate the initial therapeutic effect of XNJS.Methods:The protocol for a non-randomized controlled trial is designed in which 72 eligible patients will be allocated to one of two groups.The control group(n=36)will receive standard treatment for AIS,the test group(n=36)will receive XNJS and standard treatment.Patients will be recruited after stroke onset and will receive the intervention continuously over 10±1 days,with a follow-up period of 90 days.The primary outcome will be the change in the NIHSS,BI,mRS scores.All outcome measures will be assessed at inception,after the intervention(10±1 days),and at the follow-up(90 days).The results will be disseminated to the public through peerreviewed journals and academic conferences.Discussion:The study will provide evidence of the preliminary effects.展开更多
Ojective:To explored the effectiveness and safety of acupuncture at back-shu points of five zang and Geshu(BL 17)for bipolar depression,and its mechanism from the aspect of the anti-inflammatory response.Background:Bi...Ojective:To explored the effectiveness and safety of acupuncture at back-shu points of five zang and Geshu(BL 17)for bipolar depression,and its mechanism from the aspect of the anti-inflammatory response.Background:Bipolar disorder is a very common,often misdiagnosed mental disorder strongly associated with comorbidity,disability,and premature mortality.Bipolar depression(ie,depressive episode in bipolar disorder)is poorly responsive to available treatments.Acupuncture at back-shu points of five zang and Geshu(BL 17),a prescription from Dr.Leting Wang,is a popular therapy for depression in China.Its effectiveness and safety for bipolar depression are yet to be verified by clinical studies.Methods:The study is a single-center,prospective,randomized controlled trial involving 72 patients diagnosed with bipolar depression.Participants will be randomized either to the study group or the control group in a 1:1 ratio.All participants will receive mood stabilizer therapy.In addition,the study group will receive acupuncture therapy at back-shu points of five zang and Geshu(BL 17),three times per week.The control group will orally take the antidepressant bupropion.Observation and intervention will last for 8 consecutive weeks.Outcome measurements include Hamilton Depression Rating Scale-17,Hamilton Anxiety Rating Scale,Clinical Global Impression Scale,Young Manic Rating Scale,Treatment Emergent Symptom Scale,serum levels of anti-inflammatory cytokines[interleukin-4(IL-40),IL-10,and transforming growth factor–β,pro-inflammatory cytokines(IL-1β,IL-6,and tumor necrosis factor–α),brain-derived neurotrophic factor,and C-reactive protein.Assessments will be conducted at baseline,first,second,fourth,and eighth weeks after randomization.Safety assessments will be performed throughout the study.Discussion:The results of this study are expected to verify the effectiveness and safety of acupuncture at back-shu points of five zang and Geshu(BL 17)for bipolar depression,and explore its therapeutic mechanisms from the point of anti-inflammation.展开更多
Background： With the worldwide use and modern development of acupuncture-moxibustion, there is disagreement on its basic definition. There has been an obstacle for clinical practice, research, and legislation. Consid...Background： With the worldwide use and modern development of acupuncture-moxibustion, there is disagreement on its basic definition. There has been an obstacle for clinical practice, research, and legislation. Considering this challenge, the World Federation of Acupuncture-Moxibustion Societies proposes to develop the definition and basic scope of acupuncture-moxibustion with a Delphi study. Methods： A reactive Delphi method will be used to ask a group of experts to rate the relevance and clarity of a predesigned initial item list. This list was generated by the steering committee through a literature review and group discussion. Forty experts will be selected from many disciplines and continents to ensure appropriate representation. Predefined rules will be applied to modify the items until a consensus is achieved. After achieving the consensus on all items through the survey round, the steering committee will form the definition and basic scope of acupuncture-moxibustion by organizing a literal statement with a detailed explanation.展开更多
Objective Diminished ovarian reserve(DOR)can lead to early menopause,poor fecundity,and an increased risk of disorders such as osteoporosis,cardiovascular disease,and cognitive impairment,seriously affecting the physi...Objective Diminished ovarian reserve(DOR)can lead to early menopause,poor fecundity,and an increased risk of disorders such as osteoporosis,cardiovascular disease,and cognitive impairment,seriously affecting the physical and mental health of women.There is still no safe and effective strategy or method to combat DOR.We have developed a novel Chinese herbal formula,Tongji anti-ovarian aging 101(TJAOA101),to treat DOR.However,its safety and efficacy need to be further validated.Methods In this prospective and pre-post clinical trial,100 eligible patients aged 18–45 diagnosed with DOR will be recruited.All participants receive TJAOA101 twice a day for 3 months.Then,comparisons before and after treatment will be analyzed,and the outcomes,including anti-mullerian hormone(AMH)and follicle-stimulating hormone(FSH)levels and the antral follicle count(AFC),the recovery rate of menopause,and the Kupperman index(KMI),will be assessed at baseline,every month during medication(the intervention period),and 1,3 months after medication(the follow-up period).Assessments for adverse events will be performed during the intervention and follow-up periods.Conclusion A multicenter,prospective study will be conducted to further confirm the safety and efficacy of TJAOA101 in treating DOR and to provide new therapeutic strategies for improving the quality of life in DOR patients.展开更多
In this study,we aim to combine gene transfection techniques with the modeling methods previously employed by the research group to deeply investigate the corresponding theories of traditional Chinese medicine regard...In this study,we aim to combine gene transfection techniques with the modeling methods previously employed by the research group to deeply investigate the corresponding theories of traditional Chinese medicine regarding“myocardial energy metabolism”and“aortic thrombosis”.Our goal is to elucidate the biological mechanism underlying the occurrence and development of coronary heart disease with blood stasis syndrome from the perspectives of“heart and vessels”and“Qi(in traditional Chinese medicine,it refers to the most fundamental and subtle substances that constitute the human body and maintain life activities.At the same time,it also has the meaning of physiological function.In terms of traditional Chinese medicine,Qi and different words are used together to express different meanings)and blood”.The research content is divided into four modules as follows:1.establishment of an animal model of coronary heart disease with blood stasis syndrome through fibrinogen overexpression.2.Investigation of the mitochondrial quality control system in coronary heart disease with blood stasis syndrome under fibrinogen overexpression.3.Study of platelet autophagy in coronary heart disease with blood stasis syndrome under fibrinogen overexpression.4.Examination of the relationship between the AMPK-mTOR pathway and metabolism in platelet autophagy of coronary heart disease with blood stasis syndrome under fibrinogen overexpression.Ninety-six Sprague Dawley rats will be randomly assigned to the following groups:control group,model group,fibrinogen group and adeno-associated virus group.All rats will undergo a 14-week model construction process,and modern molecular biology methods will be employed to evaluate the model and examine relevant research indicators.The obtained data will be analyzed according to a predefined statistical analysis plan.展开更多
Objective:To determine the efficacy and safety of the Yinmei Kuijie decoction combined with 5-ami-nosalicylic acid(5-ASA)in treating mildly to moderately active ulcerative colitis(UC)under real-world conditions.Method...Objective:To determine the efficacy and safety of the Yinmei Kuijie decoction combined with 5-ami-nosalicylic acid(5-ASA)in treating mildly to moderately active ulcerative colitis(UC)under real-world conditions.Methods:This multicenter,prospective,non-randomized,observational study will be conducted in real-world settings.A total of 204 eligible patients will be consecutively enrolled in the study.Patients in the combination treatment group will receive Yinmei Kuijie decoction in combination with 5-ASA,whereas those in the control group will be treated with 5-ASA alone.The primary endpoint will be a clinical response at week 12,defined as a≥3 point and≥30%reduction from baseline in the Mayo total score with≥1 reduction in rectal bleeding or rectal bleeding score=0 or 1.Secondary efficacy endpoints at week 12 will include health-related quality of life,mucosal healing,and inflammation indicators.Conclusion:The results of this study may provide evidence of the efficacy and safety of Yinmei Kuijie decoction combined with 5-ASA in treating patients with mildly to moderately active UC under real-world principles.The results will provide a basis for further confirmatory studies on the efficacy of Yinmei Kuijie decoction.展开更多
BACKGROUND： Traditional Chinese medicine （TCM） is considered an important complementary therapy with beneficial effects for cancer patients. Elderly patients with non-small-cell lung cancer （NSCLC） are a complex ...BACKGROUND： Traditional Chinese medicine （TCM） is considered an important complementary therapy with beneficial effects for cancer patients. Elderly patients with non-small-cell lung cancer （NSCLC） are a complex patient group with increasing co-morbidity and shrinking physiological reserve, and may derive substantial benefit from the supportive aspects of TCM Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer. This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC. METHODS AND DESIGN： This is a double-blind controlled, multi-center, and prospective study with randomly selected participants from elderly NSCLC patients in China. Seventy-six patients who meet the inclusion criteria will be allocated into two groups, which will receive treatments of 3-week single-agent chemotherapy with TCM or placebo for four cycles Progression-free survival （PFS） is the primary end point, and the secondary end points are overall survival, objective response rate, time-to-progression, and quality of life （EORTC QLQ-LC43, and TCM syndrome score） Meanwhile, other end points such as toxicity, side effects and safety of the treatments will be assessed. DISCUSSION： Results from this study may provide evidence on the effectiveness, and parameters for the usage of single-agent chemotherapy combined with or without TCM on PFS of elderly patients with NSCLC.展开更多
基金supported by the Unveiling and Leading Projects of Beijing University of Chinese Medicine(No.2023-JYB-JBQN-014)the China Association of Chinese Medicine Young Talent Support Project(No.CACM-2022-QNRC2-A02).
文摘Background:Mesalazine preparations serve as first-line therapy for active mild-to-moderate ulcerative colitis(UC),however,not all patients respond to mesalazine.Patients with mesalazine-refractory UC often switch to corticosteroids,immunological therapy,and biological agents,but their use is limited owing to their well-characterised side effects(e.g.osteoporosis and cushingoid feature).Therefore,there is an unmet medical need for novel treatments with a manageable safety profile for patients with mesalazine-refractory UC.New Wumei Pill is a novel and effective herbal prescription for the treatment of UC,and our preliminary study suggested that New Wumei Pill has a significant effect on patients with mesalazine-refractory UC.However,its effectiveness and safety has not been evaluated convincingly.Objectives:This trail aims to evaluate efficacy,safety and mechanisms of New Wumei Pill in the treatment of patients with mesalazine-refractory UC.Methods:This is a prospective,randomized,double-blind control trial,in which 72 patients with mesalazine-refractory mild-to-moderate UC will be randomized in a 1:1 ratio in the treatment and control group.Patients will be screened for eligibility at the outpatient and ward of the Department of Gastroenterology in Dongfang Hospital,Beijing University of Chinese Medicine.72 participants will undergo strict screening to meet the diagnostic criteria of mildly to moderately active UC,with modified Mayo score of 3-10 points.All patients will be administered by mesalazine enteric-coated tablets for 8 weeks,at the same time,the patients in treatment group will receive New Wumei Pill,while patients from control group will be administered by dummy New Wumei Pill.Results:The primary outcomes are clinical efficacy rate and clinical remission rate according to the modified Mayo score.The secondary outcomes are individual symptom score,TCM syndrome score,endoscopic response rate,mucosal healing rate,and quality of life scale score.Finally,biological samples from participants will be preserved to reveal the mechanisms of New Wumei Pill on UC.Conclusions:We hypothesize that the patients with mesalazine-refractory mild-to-moderate UC will benefit from New Wumei Pill.If successful,this trial will provide evidence of traditional Chinese medicine in the treatment of UC,and hold promises for novel options UC patients and policymakers.
基金supported by grants from Pudong New Area Traditional Chinese Medicine Brand Multiplication Plan-Chronic Nephropathy(PDZY-2021-0302)Construction of He Liqun’s famous TCM studio(PDZY-2022-0703)+2 种基金Clinical Observation on the Efficacy of Guben Tongluo Formula in Treating Chronic Kidney Disease Phase 1-3(PW2022D-12)Pilot Project of Inheritance,Innovation and Development of Traditional Chinese Medicine in Pudong New Area(YC-2023-0602)Pudong New Area’s Peak and Plateau Discipline Development in Clinical Medicine for Novel and Special Diseases(2025-PWXZ-15).
文摘Introduction:With the incidence of chronic kidney disease(CKD)increasing year by year,it is particularly important to intervene in the early stage of CKD(stages 1–3).Unfortunately,the effective drug treatment methods for CKD(stages 1–3)are lacking.Guben Tongluo Formula(GTF)is the experience formula of Professor Liqun He,a famous traditional Chinese medicine(TCM)doctor in Shanghai.Our previous studies demonstrated that GTF might effectively alleviate CKD via multi-mechanisms.As the first angiotensin-2 receptor antagonist for treating hypertension,losartan potassium(LP)could effectively reduce blood pressure,decrease cardiovascular risk,and delay the occurrence of end-stage renal disease.Thus,we design this clinical protocol of GTF combining LP to observe the efficacy and safety of GTF and try to provide a novel drug treatment method for treating CKD(stages 1–3)patients.Methods and analysis:This is a multicenter randomized controlled clinical trial.160 participants will be enrolled in this trial and divided into LP group,GTF group,LP+GTF group,and placebo group randomly assigning 1:1:1:1 principle.LP group will receive general treatments combining LP,GTF group will receive general treatments combining GTF,and the GTF+LP group will receive general treatments combining GTF and LP.Placebo group will receive general treatments combining placebo treatment.The primary evaluation index will be the change of serum creatinine after treatment.Secondary evaluation indexes include changes in blood urea nitrogen,serum uric acid,estimated glomerular filtration rate,etc.;immune indicators and renal fibrosis indicators,as well as TCM symptoms.Besides,vital sign indicators and adverse events will be closely observed.Ethics and dissemination:The protocol has been approved by the Ethics Committee of Seventh People’s Hospital of Shanghai University of Traditional Chinese Medicine(reference number:2024-7th-HIRB-094)and other ethics committees at each center.With the implementation of this clinical trial,it would offer a TCM formula for the treatment of CKD(stages 1–3)and clarify the underlying mechanism of GTF for alleviating CKD.Trial registration:This trial is registered with ChiCTR2400090125 and registered on September 24,2024.
文摘BACKGROUND： Rheumatoid arthritis（RA） is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, until now Western acupuncture studies on RA have not shown conclusive positive results. Acupuncture is regarded as a reflex therapy that has effects on the human autonomic nervous system. By establishing a traditional Chinese medicine（TCM） diagnosis first, the practitioner is able to choose acupoints according to the state of each individual patient.METHODS/DESIGN： We are interested if acupuncture, using a classical diagnostic procedure to allocate acupoints to the patient according to the Shang Han Lun theory, can be effective in relieving pain, improving hand function and increasing health-related quality of life in RA.The authors intend to harmonize TCM diagnosis according to clinical and genetic profiles. Patients with the TCM diagnosis of a so-called Turning Point syndrome will be followed up in a randomized, prospective, double-blind, placebo-controlled, multicenter and three-armed parallel-group study with a standardized treatment in order to optimize potential therapeutic effects of acupuncture on pain, strength and muscle function of patients with RA as well as the influence on inflammation and quality of life.DISCUSSION： The findings of this study will provide important clinical information about the feasibility and efficacy of acupuncture treatment for RA patients. In addition, it will explore the feasibility of further acupuncture research.TRIAL REGISTRATION NUMBER： Clinical Trials.gov Identifier NCT02553005.
基金supported by 2011 Special Fund for TCM-scientific Research in the Public Interest of Ministry of Finance, People’s Republic of ChinaState Administration of Traditional Chinese Medicine (No. 201107002)
文摘BACKGROUND： Chronic obstructive pulmonary disease （COPD） is a major public health problem worldwide. Pulmonary rehabilitation （PR） is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China. METHODS AND DESIGN： A multicenter, randomized, controlled trial will be conducted. A total of 464 patients meeting the inclusion criteria will be enrolled into this study with 232 patients in each of the trial group and the control group. Based on patient education, patients in the trial group will receive pulmonary Daoyin and continue with their usual therapy for three months. In the control group, patients will continue with their usual therapy. The primary outcome measures are exercise capacity assessed by the six-minute walking distance test and lung function. Secondary outcomes include dyspnea and quality of life. Measurements will be taken at baseline （month 0） and after the study period （month 3）. DISCUSSION： It is hypothesized that pulmonary Daoyin will have beneficial effects in improving exercise capacity and psychosocial function of patients with stable COPD, and will provide an alternative form of exercise training that is accessible for the large number of people with COPD. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is NCT01482000.
基金This study was sponsored by National Key R&D Program of China(No.2O18YFC13131OO)Sanming Project of Medicine in Shenzhen(No.SZSM201911015)CAMS Innovation Fund for Medical Sciences(CIFMS)(No.2019-I2M-2-004).
文摘Objective:National Health Commission of the People's Republic of China collaborated with many ministries and commissions government and initiated a population-based cancer screening program in high-risk area of rural China,targeting three types of cancer that are most prevalent in these areas,including esophageal,stomach and liver cancer.This study protocol was reported to show the design and evaluate the effectiveness of cancer screening and appropriate screening strategies of three cancers in rural China.Methods and analysis:A two-step design with cancer risk assessment based on questionnaire interview,Hepatitis B surface antigen(HBsAg)test strip and subsequent clinical intervention for high-risk populations was adopted&ee of charge at the local hospitals designated in the program.Ethic and dissemination:This study was approved by the Institutional Review Board of Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College.The results will evaluate the effectiveness of cancer screening and appropriate screening strategies in rural China.
基金supported by the National Key Research and Development Program of China,No.2017YFA0105403(to LMR)the Key Research and Development Program of Guangdong Province of China,No.2019B020236002(to LMR)+4 种基金The Clinical Innovation Research Program of Guangzhou Regenerative Medicine and Health Guangdong Laboratory of China,No.2018GZR0201006(to LMR)the National Natural Science Foundation of China,Nos.81772349(to BL),31470949(to BL)the Guangzhou Science and Technology Project of China,Nos.201704020221(to LMR),201707010115(to BL)the Natural Science Foundation of Guangdong Province of China,No.2017A030313594(to BL)the Medical Scientific Research Foundation of Guangdong Province of China,No.A2018547(to MP)
文摘Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.
文摘BACKGROUND： Postoperative gastrointestinal dysfunction（PGD） is one of the most common complications following major surgeries under general anesthesia（GA）. Despite ongoing research and new drug treatments, abdominal distension within 24 h postoperatively occurs in 8%–28% of all surgeries. We aim to analyze the effectiveness of preventing PGD by preoperatively stimulating Neiguan（PC6）, Zusanli（ST36） and Shangjuxu（ST37） bilaterally twice a day compared with sham-acupuncture treatment and standard treatment.METHODS AND DESIGN： This is a single-center, prospective practical randomized controlled trial. All groups will be given standard treatments. Patients undergoing vascular surgery under GA will be included from the Vascular Surgery Unit in West China Hospital of Sichuan University, China, and divided into three groups. The experimental group will receive routine treatments and acupuncture at PC6, ST36 and ST37 bilaterally with electrical stimulation twice a day for 20 min preoperatively. The sham-acupuncture group will receive pseudo-electroacupuncture at sham acupoints of PC6, ST36 and ST37, which are 1 cun away from the real acupoints. The routine-treatment group will not receive electroacupuncture. The outcomes include the incidence of abdominal distention, abdominal circumference, the degree of abdominal distension, the fi rst time of fl atus and defecation, and hospitalization duration. DISCUSSION： The results from this study will demonstrate whether preoperative electroacupuncture is an effective method for the prevention of PGD in patients undergoing vascular surgery under GA. This study may also provide a standardized acupuncture treatment for reduction of PGD. TRIAL REGISTRATION： This study is registered with the Chinese Clinical Trial Registry： Chi CTR-TRC-13003649.
基金supported by the National Natural Science Foundation of China (No. 81202846)the China Academy of Chinese Medical Sciences (No. Z0221)
文摘BACKGROUND： Despite a recent American Heart Association （AHA） consensus statement emphasizing the importance of resistant hypertension （RH）, its control is still a challenge for conventional medicine. The Chinese herbal formula, Qutan Huayu Fang, has been used effectively to assist antihypertensive agents in blood pressure control, but its effect for RH patients is still unclear. This pilot study aims to explore the effects of taking the formula in addition to antihypertensive medication in the management of RH. METHODS/DESIGN： A prospective cohort study will be conducted in two first-class hospitals of traditional Chinese medicine （TCM）. Eligible RH patients will be classified as the experimental group （n = 100） and the control group （n = 100） based on the interventions they receive. Participants taking antihypertensive agents and the Chinese herbal formula will be in the experimental group and those taking antihypertensive agents alone will be in the control group. The whole study will last 24 weeks, including an 8-week observation and follow-up at 24 weeks. The primary outcomes, assessed against patient baseline conditions, will be the reduction of systolic blood pressure and diastolic blood pressure as well as changes in TCM symptoms and signs. These outcomes will be assessed at weeks 2, 4, 6, and 8. The reductions of blood pressure will also be assessed at week 24. Cardiac events and mortality rate will be secondary outcomes and will be assessed at weeks 8 and 24. Any adverse reactions will be recorded during the study. The causal inference method will be used to assess the effectiveness of the inclusion of TCM herbal medicine in the management of patients with RH. DISCUSSION： This study will determine whether the Chinese herbal formula is helpful for RH patients treated with antihypertensive agents and the findings will provide a basis for further confirmatory studies TRIAL REGISTRATION NUMBER： ClinicalTria/s.gov Identifier NCT01904695
基金Supported by Study of Press Needle on Immune Function in Breast Cancer Patients after Radical Mastectomy(No.20ZL15)Enhancement of Scientific Research Capacity of“Hundred Talents Program”(No.20-Q17)。
文摘Radical mastectomy may lead to suppression of cellular immune function in patients with malignant tumors,and affect the quality of life(QOL)of patients.Immune suppression is a common cause of complications and adverse reactions in adjuvant therapy after radical mastectomy of breast cancer.Currently,there are few proven effective treatments for immune suppression.Therefore,it’s necessary to develop a new treatment method.Press needle is widely used in clinical practice.However,there have been relatively few studies that evaluate the effects of press needle on postoperative immune function.The aim of the present study is to assess the effects of press needle on immune function and QOL in female breast cancer patients undergoing radical mastectomy.This study will be a single-center,randomized and single-blinded trial.Totally 78 eligible patients will be randomized in a ratio of 1:1 to the press needle group or the sham press needle group.During the treatment phase,patients will undergo five times weekly of verum press needle or sham press needle for 2 weeks.The primary outcome measures will be the peripheral blood levels of CD8^(+),CD4^(+),CD3^(+),and CD4^(+)/CD8^(+)T cells.The secondary outcome measures will be the changes of patients’QOL,evaluated by the Karnofsky Performance Scale score and the EORTC core quality of life questionnaire(EORTC QLQ-C30).Furthermore,5-year survival rate and recurrence rate will be evaluated.Safety and adverse events will be assessed at each visit.The results of this on-going study will provide clinical evidence for the effects and safety of press needle on immune function and QOL in patients after breast cancer resection compared with sham press needle.
基金the Administration of Traditional Chinese Medicine of Zhejiang Province (No.2021ZB145)The Inheritance Studio Construction Project of National Famous Old Chinese Medicine Experts of Dr.Wang Zhanglian [Letter of the Department of Personnel and Education of the National Administration of Traditional Chinese Medicine,No.(2022) 75]
文摘Acupuncture has been widely used as an alternative and complementary therapy for premature ovarian insufficiency(POI)in China.However,research to date has not shown that acupuncture is effective for POI compared with hormone replacement therapy(HRT).We will conduct a randomized,controlled,and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on POI.Seventy-six patients with POI will be randomly assigned to two groups.The treatment group will receive twenty-eight one-hour sessions of acupuncture treatments,and the control group will receive 12-week HRT.The whole study will consist of a 12-week treatment plan and a 12-week follow-up session.The primary outcome is measured by changes in serum anti-Müllerian hormone and follicle-stimulating hormone(FSH)levels at weeks 12 and 24.Secondary outcome measures include estradiol,luteinizing hormone(LH),LH/FSH ratio,Kupperman index,and menstrual condition.This trial is expected to clarify whether or not acupuncture is effective and safe for POI compared with HRT.
基金The research was supported by the Department of Science and Technology of the National Administration of Traditional Chinese Medicine Local Project of Central Financial Transfer Payment in 2021(grant no.2021JDBZTS-01).
文摘Background: The Xingnao Kaiqiao acupuncture method, founded by Academician ShiXuemin, has outstanding efficacy in the treatment of ischemic stroke and has been widelyused at home and abroad. However, after half a century of animal experiments and clinicalstudies, clearly and intuitively revealing its therapeutic mechanism is still a great challengefor researchers. Therefore, this experiment is based on the combination of medicine andengineering to study the immediate effects of the acupuncture method in treating patientsby recording the electroencephalography (EEG) activities of subjects during the acupunctureprocess and to further reveal the therapeutic mechanism at the brain level. Methods: Thistrial is an exploratory, prospective, single-arm interventional study involving a total ofpatients with ischemic stroke. Physicians will record EEG data from patients duringacupuncture as the primary outcome indicator. After pre-processing the EEG data,researchers will use various methods to analyze the immediate effects of acupuncture toobtain brain effectiveness. Deep learning will then be used to identify acupoint stimuli andreceive correspondence between the acupuncture effect and the brain’s internal state.National Institutes of Health Stroke Scale score before and after the acupuncture process willbe used as the secondary outcome indicator. Conclusion: This is the first study protocol toapply dynamic changes in EEG to explore a range of mechanisms of action of acupuncture inthe treatment of ischemic stroke. We propose a method to analyze EEG signals ofacupuncture patients. The deep learning model will be applied for supervised training toobtain the compelling relationship between the acupuncture method and internal brainstates, providing a new prospect for the digitization of traditional Chinese medicine.
文摘Background： Vulvodynia, or vulvar pain, is a common condition in women; however, there are few evidence-based clinical trials evaluating nonpharmacological therapies for this condition. Acupuncture is one complementary and integrative medicine therapy used by some patients with vulvodynia. This study evaluates two different acupuncture strategies for the treatment of vulvodynia and aims to evalu- ate whether either of the acupuncture protocols reduces vulvar pain, pain duration or pain with inter- course. The study also examines how long the effect of acupuncture lasts in women with vulvodynia. Methods/design： The study is designed as a randomized controlled trial, focused on two acupuncture protocols. Fifty-one patients who have had vulvodynia for more than 3 months will be recruited. Among them, 34 patients will be randomized into Groups la and 1b; those who are unwilling to receive acupuncture will be recruited into the standard care group （Group 2）. Patients in Group la will have acupuncture focused on the points in the pudendal nerve distribution area, while patients in Group lb will receive acupuncture focused on traditional （distal） meridian points. Patients in Group 2 will receive routine conventional treatments, such as using pain medications, local injections and physical therapies or other nonsurgical procedures. Acupuncture will last 45 min per session, once or twice a week for 6 weeks. The primary outcome measurement will be objective pain intensity, using the cotton swab test. The secondary outcome measurement will be subjective patient self-reported pain intensity, which will be conducted before cotton swab test. Pain intensities will be measured by an 11-point Numeric Pain Rating Scale. Pain duration and pain score during intercourse are recorded. Local muscle tension, tender- ness and trigger points （Ashi points） are also recorded. All measurements will be recorded at baseline （before the treatment）, at the end of each week during treatment and at the end of the 6weeks. Follow-up will be done 6 weeks following the last treatment. Discussion： Results of this trial will provide preliminary data on whether acupuncture provides better outcomes than nonacupuncture treatments, i.e., standard care, and whether acupuncture focused on the points in pudendal nerve distribution, near the pain area, has better results than traditional acupunc- ture focused on distal meridian points for vulvodynia.
基金supported by the Fundamental Research Funds for the Central Public Welfare Research Institutes(grant number No.Z0646).
文摘Objective:The washing prescription for lower limb sprains(WPFLLS)has acceptable effects on chronic ankle sprains(CAS).To provide additional evidence supporting the efficacy of the WPFLLS prescription,we designed a multicenter,double-blind,randomized controlled trial with professional ballet dancers who have a high incidence of chronic ankle sprain as the study subjects.Materials and methods:This is a multicenter,double-blind,randomized controlled trial.According to the strict inclusion and exclusion criteria,120 ballet dancers with CAS will be selected and randomly assigned to the traditional Chinese medicine(TCM)group or to the placebo group.Patients will be treated for 14 consecutive days and followed up for 28 days.The primary outcome is the ankle-hindfoot score of the American Orthopaedic Foot&Ankle Society(AOFAS).The secondary outcomes encompass the Visual Analog Scale(VAS),the Symptom Severity and Dance Performance Quality Index,and the frequency and dosage of externally applied rescue medication.Conclusions:This trial will provide high-quality clinical evidence on the efficacy and safety of WPFLLS in the treatment of CAS and provide clinical recommendations for subsequent studies on WPFLLS.
基金Changchun Science and Technology Development Project(No.21ZGM32)Natural Science Foundation of Jilin Province(No.20200201412JC).All funds conflict-free.
文摘Objective:Acute ischemic stroke(AIS)is characterized by high morbidity and high mortality.In recent years,complementary and alternative medicine has gradually been widely accepted and applied.At present,traditional Chinese medicine therapy and standard treatments are used for the treatment of AIS.Xingnao-Jianshen prescriptions(XNJS)is an effective prescription for the clinical treatment of AIS,but there is a lack of large-scale clinical evidence to confirm its clinical efficacy.Therefore,our team designed this protocol to evaluate the initial therapeutic effect of XNJS.Methods:The protocol for a non-randomized controlled trial is designed in which 72 eligible patients will be allocated to one of two groups.The control group(n=36)will receive standard treatment for AIS,the test group(n=36)will receive XNJS and standard treatment.Patients will be recruited after stroke onset and will receive the intervention continuously over 10±1 days,with a follow-up period of 90 days.The primary outcome will be the change in the NIHSS,BI,mRS scores.All outcome measures will be assessed at inception,after the intervention(10±1 days),and at the follow-up(90 days).The results will be disseminated to the public through peerreviewed journals and academic conferences.Discussion:The study will provide evidence of the preliminary effects.
基金funded by the Beijing Municipal Administration of Hospitals Incubating Program(No.PZ2022032).
文摘Ojective:To explored the effectiveness and safety of acupuncture at back-shu points of five zang and Geshu(BL 17)for bipolar depression,and its mechanism from the aspect of the anti-inflammatory response.Background:Bipolar disorder is a very common,often misdiagnosed mental disorder strongly associated with comorbidity,disability,and premature mortality.Bipolar depression(ie,depressive episode in bipolar disorder)is poorly responsive to available treatments.Acupuncture at back-shu points of five zang and Geshu(BL 17),a prescription from Dr.Leting Wang,is a popular therapy for depression in China.Its effectiveness and safety for bipolar depression are yet to be verified by clinical studies.Methods:The study is a single-center,prospective,randomized controlled trial involving 72 patients diagnosed with bipolar depression.Participants will be randomized either to the study group or the control group in a 1:1 ratio.All participants will receive mood stabilizer therapy.In addition,the study group will receive acupuncture therapy at back-shu points of five zang and Geshu(BL 17),three times per week.The control group will orally take the antidepressant bupropion.Observation and intervention will last for 8 consecutive weeks.Outcome measurements include Hamilton Depression Rating Scale-17,Hamilton Anxiety Rating Scale,Clinical Global Impression Scale,Young Manic Rating Scale,Treatment Emergent Symptom Scale,serum levels of anti-inflammatory cytokines[interleukin-4(IL-40),IL-10,and transforming growth factor–β,pro-inflammatory cytokines(IL-1β,IL-6,and tumor necrosis factor–α),brain-derived neurotrophic factor,and C-reactive protein.Assessments will be conducted at baseline,first,second,fourth,and eighth weeks after randomization.Safety assessments will be performed throughout the study.Discussion:The results of this study are expected to verify the effectiveness and safety of acupuncture at back-shu points of five zang and Geshu(BL 17)for bipolar depression,and explore its therapeutic mechanisms from the point of anti-inflammation.
基金Supported by the China Association for Science and Technology(No.JXJY2015071)
文摘Background： With the worldwide use and modern development of acupuncture-moxibustion, there is disagreement on its basic definition. There has been an obstacle for clinical practice, research, and legislation. Considering this challenge, the World Federation of Acupuncture-Moxibustion Societies proposes to develop the definition and basic scope of acupuncture-moxibustion with a Delphi study. Methods： A reactive Delphi method will be used to ask a group of experts to rate the relevance and clarity of a predesigned initial item list. This list was generated by the steering committee through a literature review and group discussion. Forty experts will be selected from many disciplines and continents to ensure appropriate representation. Predefined rules will be applied to modify the items until a consensus is achieved. After achieving the consensus on all items through the survey round, the steering committee will form the definition and basic scope of acupuncture-moxibustion by organizing a literal statement with a detailed explanation.
基金supported by grants from the National Natural Science Foundation of China(No.82001498 and No.82002768)the Natural Science Foundation of Hubei Province(No.2020CFB544)The Clinical Research Pilot Project of Tongji Hospital,Huazhong University of Science and Technology(No.2019CR205).
文摘Objective Diminished ovarian reserve(DOR)can lead to early menopause,poor fecundity,and an increased risk of disorders such as osteoporosis,cardiovascular disease,and cognitive impairment,seriously affecting the physical and mental health of women.There is still no safe and effective strategy or method to combat DOR.We have developed a novel Chinese herbal formula,Tongji anti-ovarian aging 101(TJAOA101),to treat DOR.However,its safety and efficacy need to be further validated.Methods In this prospective and pre-post clinical trial,100 eligible patients aged 18–45 diagnosed with DOR will be recruited.All participants receive TJAOA101 twice a day for 3 months.Then,comparisons before and after treatment will be analyzed,and the outcomes,including anti-mullerian hormone(AMH)and follicle-stimulating hormone(FSH)levels and the antral follicle count(AFC),the recovery rate of menopause,and the Kupperman index(KMI),will be assessed at baseline,every month during medication(the intervention period),and 1,3 months after medication(the follow-up period).Assessments for adverse events will be performed during the intervention and follow-up periods.Conclusion A multicenter,prospective study will be conducted to further confirm the safety and efficacy of TJAOA101 in treating DOR and to provide new therapeutic strategies for improving the quality of life in DOR patients.
基金This work was supported by the National Natural Science Foundation of China(No.81973753 to Jian WX)Hunan Postgraduate Scientific Research Innovation Project(CX 20220781)Hunan University Students’Innovation and Entrepreneurship Training Program(S202210541116).
文摘In this study,we aim to combine gene transfection techniques with the modeling methods previously employed by the research group to deeply investigate the corresponding theories of traditional Chinese medicine regarding“myocardial energy metabolism”and“aortic thrombosis”.Our goal is to elucidate the biological mechanism underlying the occurrence and development of coronary heart disease with blood stasis syndrome from the perspectives of“heart and vessels”and“Qi(in traditional Chinese medicine,it refers to the most fundamental and subtle substances that constitute the human body and maintain life activities.At the same time,it also has the meaning of physiological function.In terms of traditional Chinese medicine,Qi and different words are used together to express different meanings)and blood”.The research content is divided into four modules as follows:1.establishment of an animal model of coronary heart disease with blood stasis syndrome through fibrinogen overexpression.2.Investigation of the mitochondrial quality control system in coronary heart disease with blood stasis syndrome under fibrinogen overexpression.3.Study of platelet autophagy in coronary heart disease with blood stasis syndrome under fibrinogen overexpression.4.Examination of the relationship between the AMPK-mTOR pathway and metabolism in platelet autophagy of coronary heart disease with blood stasis syndrome under fibrinogen overexpression.Ninety-six Sprague Dawley rats will be randomly assigned to the following groups:control group,model group,fibrinogen group and adeno-associated virus group.All rats will undergo a 14-week model construction process,and modern molecular biology methods will be employed to evaluate the model and examine relevant research indicators.The obtained data will be analyzed according to a predefined statistical analysis plan.
基金supported by the Key Project of Traditional Chinese Medicine in Anhui Province(202303a07020003)Basic Research Expenses of Beijing University of Chinese Medicine(2024-JYB-JBZD-044)Vertical Development Fund of Beijing University of Chinese Medicine(2023-ZXFZJJ-005).
文摘Objective:To determine the efficacy and safety of the Yinmei Kuijie decoction combined with 5-ami-nosalicylic acid(5-ASA)in treating mildly to moderately active ulcerative colitis(UC)under real-world conditions.Methods:This multicenter,prospective,non-randomized,observational study will be conducted in real-world settings.A total of 204 eligible patients will be consecutively enrolled in the study.Patients in the combination treatment group will receive Yinmei Kuijie decoction in combination with 5-ASA,whereas those in the control group will be treated with 5-ASA alone.The primary endpoint will be a clinical response at week 12,defined as a≥3 point and≥30%reduction from baseline in the Mayo total score with≥1 reduction in rectal bleeding or rectal bleeding score=0 or 1.Secondary efficacy endpoints at week 12 will include health-related quality of life,mucosal healing,and inflammation indicators.Conclusion:The results of this study may provide evidence of the efficacy and safety of Yinmei Kuijie decoction combined with 5-ASA in treating patients with mildly to moderately active UC under real-world principles.The results will provide a basis for further confirmatory studies on the efficacy of Yinmei Kuijie decoction.
基金supported by the Longhua Medicial Project (D-11)The Science and Technology Commission of Shanghai Municipality (No.12401905700)
文摘BACKGROUND： Traditional Chinese medicine （TCM） is considered an important complementary therapy with beneficial effects for cancer patients. Elderly patients with non-small-cell lung cancer （NSCLC） are a complex patient group with increasing co-morbidity and shrinking physiological reserve, and may derive substantial benefit from the supportive aspects of TCM Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer. This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC. METHODS AND DESIGN： This is a double-blind controlled, multi-center, and prospective study with randomly selected participants from elderly NSCLC patients in China. Seventy-six patients who meet the inclusion criteria will be allocated into two groups, which will receive treatments of 3-week single-agent chemotherapy with TCM or placebo for four cycles Progression-free survival （PFS） is the primary end point, and the secondary end points are overall survival, objective response rate, time-to-progression, and quality of life （EORTC QLQ-LC43, and TCM syndrome score） Meanwhile, other end points such as toxicity, side effects and safety of the treatments will be assessed. DISCUSSION： Results from this study may provide evidence on the effectiveness, and parameters for the usage of single-agent chemotherapy combined with or without TCM on PFS of elderly patients with NSCLC.
