Objective:To evaluate the efficacy and safety of acupoint application for post-stroke depression(PSD)by regulating gastrointestinal function.A secondary objective is to explore the potential mechanism underlying this ...Objective:To evaluate the efficacy and safety of acupoint application for post-stroke depression(PSD)by regulating gastrointestinal function.A secondary objective is to explore the potential mechanism underlying this approach from the perspective of gut microbiota.Methods:This multicenter,randomized,double-blind(patients and assessors),placebo-controlled trial will enroll 80 patients with PSD,and include a 1-week run-in period,a 4-week treatment phase,and a 12-week follow-up.Eligible participants will randomly be assigned in a 1:1 ratio to either the acupoint application or placebo(non-acupoint)groups.Treatments will be administered thrice weekly for 4 weeks.The primary outcome is change in the Hamilton Rating Scale for Depression(HAMD)score.Secondary outcomes include the Beck Depression Inventory(BDI),36-Item Short-Form Health Survey(SF-36),Barthel Index of Activities of Daily Living,Social Adaptation Self-Evaluation Scale(SASS),and gut microbiota profiling.All outcomes will be assessed at baseline(prior to treatment),during treatment(weeks 2 and 4),and during follow-up(weeks 8,12,and 16).The Treatment Emergent Symptom Scale(TESS)will be used for evaluation throughout the 4-week treatment phase.Discussion:The results of this study will provide important evidence supporting a novel treatment strategy for PSD that targets gastrointestinal regulation,potentially informing future clinical practice.展开更多
Background: Insomnia is a common complaint that is closely related to gastrointestinal symptoms, which is consistent with the traditional Chinese medicine classical theory of ‘‘stomach disharmony leading to restless...Background: Insomnia is a common complaint that is closely related to gastrointestinal symptoms, which is consistent with the traditional Chinese medicine classical theory of ‘‘stomach disharmony leading to restless sleep." Acupuncture is an effective complementary and alternative medicine therapy to improve gastrointestinal function and restore the normal sleep-wake cycle. However, studies on the effectiveness of acupuncture for insomnia due to spleen-stomach disharmony syndrome are limited to case reports and few randomized controlled trials; deeper research on its mechanism is still lacking. This randomized controlled trial aims to assess the treatment efficacy of ‘‘harmonizing stomach to tranquilize mind"acupuncture for insomnia and its influence on the intestinal microbiome.Methods/design: This is a randomized, single-blind, parallel-group study. Sixty eligible patients with insomnia due to spleen-stomach disharmony syndrome will be randomly divided into two groups(1:1 allocation ratio). The intervention group will use ‘‘harmonizing stomach to tranquilize mind"acupuncture, and the control group will receive sham acupuncture. Participants will receive 5 acupuncture treatment sessions per week for 4 consecutive weeks. The Pittsburgh Sleep Quality Index will be used to evaluate the clinical efficacy of acupuncture treatment by making assessments at baseline, the end of treatment and the end of the follow-up. High-throughput 16 S ribosomal ribonucleic acid gene sequencing will be performed to detect changes in the intestinal microbial composition before and after treatment.Discussion: The results of this trial are expected to confirm that ‘‘harmonizing stomach to tranquilize mind" acupuncture can effectively relieve insomnia and alter the intestinal microbiome.展开更多
Background: Fire-needle acupuncture, an important kind of acupuncture therapy, has been clinically used to treat upper limb spastic paralysis(ULSP) after stroke. Clinical experience has indicated that fire-needle acup...Background: Fire-needle acupuncture, an important kind of acupuncture therapy, has been clinically used to treat upper limb spastic paralysis(ULSP) after stroke. Clinical experience has indicated that fire-needle acupuncture treatment takes less time, requires fewer visits, and has more rapid results and fewer side effects compared to chemical medicine alternatives. This study will evaluate the effects of fire-needle acupuncture for ULSP in the context of standardized clinical research and provide high-quality data to inform clinical procedures and future study design.Methods/Design: A randomized controlled trial will be carried out to evaluate the effects of fire-needle acupuncture therapy in patients with ULSP from stroke. ULSP patients(n = 120) will be recruited at Changhai Hospital in Shanghai, China. Patients will be randomly divided into three groups, including fire-needle acupuncture group(FAG), filiform-needle acupuncture group(FFAG) and rehabilitation treatment group(RTG). During the 3-week treatment, the FAG will be treated every two days, while FFAG and RTG will be treated 5 d in a row and then rest for 2 d. The Simplified Fugl-Meyer Motor Function Scale and Modified Ashworth Scale will be used as the primary outcome measures. Statistical analysis will be conducted by an independent statistician.Discussion: Through this study, the utility of fire-needle acupuncture in treating ULSP after stroke will be tested, and some specific claims of fire-needle acupuncture therapy will be evaluated, such as relieving spasm and muscular tension, improving activities of daily living, rapidity of response and less frequency of treatment compared with other treatments.展开更多
OBJECTIVE: To investigate the efficacy and safety of Xinglouchengqi(XLCQ) decoction in treatment of acute ischemic stroke with constipation.METHODS: In this prospective, multicenter, assessor-blinded, randomized contr...OBJECTIVE: To investigate the efficacy and safety of Xinglouchengqi(XLCQ) decoction in treatment of acute ischemic stroke with constipation.METHODS: In this prospective, multicenter, assessor-blinded, randomized controlled trial, 360 eligible participants will be randomized to the XLCQ group or the control group. Participants in the XLCQ group will receive XLCQ decoction, while those in the control group will undergo clysis therapy using glycerin enemas or oral administration of lactulose solution. Both groups will undergo a treatment period of(5 ± 2) d and a 1-month follow-up.The primary outcome measure will be the Constipation Scale score. The secondary outcome measures will include scores on the National Institutes of Health Stroke Scale, the Traditional Chinese Medicine(TCM) Stroke Scale, the Diagnostic Scale for TCM Syndromes of Ischemic Stroke and TCM Scale for Syndrome of Phlegm-heat and Fu-organ Excess.Therapeutic mechanism outcomes and safety outcomes will also be assessed. Assessments will be conducted at baseline, at the end of the treatment period, and at the follow-up. Moreover, daily visits will be scheduled to grade the status of constipation during the treatment period.DISCUSSION: The results of this study will provide scientific and objective data with which to assess the efficacy and safety of XLCQ decoction for patients with acute ischemic stroke and constipation.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
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： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does...BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.展开更多
BACKGROUND： Parkinson＇s disease （PD） is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its compl...BACKGROUND： Parkinson＇s disease （PD） is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its complex pathogenesis. Adverse effects from Western drug-based medical intervention prevent long-term adherence to these therapies in many patients. Traditional Chinese medicine （TCM） has long been used to improve the treatment of PD by alleviating the toxic and adverse effects of Western drug-based intervention. Therefore, the aim of this study is to evaluate the efficacy and safety of Xifeng Dingchan Pill （XFDCP）, a compound traditional Chinese herbal medicine, taken in conjunction with Western medicine in the treatment of PD patients at different stages in the progression of the disease. METHODS AND DESIGN： This is a multicenter, randomized controlled trial. In total, 320 patients with early- （n = 160） and middle-stage PD （n = 160） will be enrolled and divided evenly into control and trial groups. Of the 160 patients with early-stage PD, the trial group （n = 80） will be given XFDCP, and the control group （n = 80） will be given Madopar. Of the 160 patients with middle-stage PD, the trial group （n = 80） will be given XFDCP combined with Madopar and Piribedil, and the control group （n = 80） will be given Madopar and Piribedil. The Unified Parkinson＇s Disease Rating Scale scores, TCM symptoms scores, quality of life, change of Madopar＇s dosage and the toxic and adverse effects of Madopar will be observed during a 3-month treatment period and through a further 6-month follow-up period. DISCUSSION： It is hypothesized that XFDCP, combined with Madopar and Piribedil, will have beneficial effects on patients with PD. The results of this study will provide evidence for developing a comprehensive therapy regimen, which can delay the progress of the disease and improve the quality of life for PD patients in different stages. TRIAL REGISTRATION： This trial has been registered in the Chinese Clinical Trial Registry with the identifer ChiCTR-TRC-12002150.展开更多
OBJECTIVE: To investigate the effect of herb-partitioned moxibustion(HPM) on pain and quality of life in women with endometriosis.METHODS: Thirty-six patients will be randomly assigned to a treatment group or a wait-l...OBJECTIVE: To investigate the effect of herb-partitioned moxibustion(HPM) on pain and quality of life in women with endometriosis.METHODS: Thirty-six patients will be randomly assigned to a treatment group or a wait-list control group. The treatment group will receive 12 sessions of HPM in the lower abdomen and lumbosacral region for 3 months. Wait-list participants will not receive any specific treatments until the trial is completed.RESULTS: The primary outcome measure is pain intensity assessed by a Visual Analogue Scale at baseline, months 1, 2, and 3 in the treatment period,and months 4, 5, and 6 in the follow-up period. Secondary outcome measures include quality of life assessed by the Short Form 36 Health Survey, change in CA125, change in cyst diameter(assessed by ultrasound examination), and rescue medication dosage.CONCLUSION: This study will provide evidence to confirm if HPM may be used as a therapeutic option for treating endometriosis.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
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
OBJECTIVE:To conduct a multicenter randomized controlled trial of the efficacy of standardized Chinese herbal medicines(CHMs)against acuteon-chronic liver failure(ACLF)and provide reproducible and high-level evidence ...OBJECTIVE:To conduct a multicenter randomized controlled trial of the efficacy of standardized Chinese herbal medicines(CHMs)against acuteon-chronic liver failure(ACLF)and provide reproducible and high-level evidence for clinical practice.METHODS:This is a prospective,multicenter,centrally randomized controlled trial.Patients diagnosed with hepatitis B virus-related ACLF(n=510)will be allocated to the standard medical therapy or CHM group at a 1∶1 ratio.Two CHMs will be used on the basis of the traditional Chinese medicine syndrome:Liangxue Jiedu granules for excess syndromes and Yiqi Jiedu granules for deficiency syndromes.The primary outcome is transplant-free survival at week 12.The secondary outcomes are(a)transplant-free survival at week 24,(b)liver function as assessed using the model for end-stage liver disease score at week 12,(c)liver function as assessed using the Child-Pugh score at week 12,and(d)the incidence of complications at week 12.DISCUSSION:The effectiveness and safety of CHM formulations will be assessed following treatment for ACLF.TRIAL REGISTRATION:The trial was registered at Clinical Trials.gov(NCT03577938)on June 24,2018.展开更多
OBJECTIVE: To evaluate the efficacy and safety of Zhengyuan capsule(正元胶囊) when treating Cancer-related fatigue(CRF) in lung cancer patients undergoing surgical operation.METHODS/DESIGN: This is a single-center, do...OBJECTIVE: To evaluate the efficacy and safety of Zhengyuan capsule(正元胶囊) when treating Cancer-related fatigue(CRF) in lung cancer patients undergoing surgical operation.METHODS/DESIGN: This is a single-center, double-blinded, prospective, and randomized controlled trial in the Department of Integrated Chinese and Western Medicine, Shanghai Chest Hospital Shanghai Jiao Tong University, Shanghai. Eligible participants will be randomly allocated into two groups: a treatment group receiving an 8-week Zhengyuan capsule regimen therapy and a control group receiving an 8-week placebo capsule regimen therapy. Evaluation will be carried out at four timelines: the participants' screening period, baseline period, the middle of the intervention period,and the end of the intervention period. The primary outcome assessment is fatigue scoring using the Cancer Fatigue Scale(CFS) measurement system.Secondary measurements include fatigue severity assessment using the Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF) measurement system, Traditional Chinese Medicine syndrome pattern differentiation, levels of immunologic indicators(TNF-α, IL-6, IL-1, T lymphocytes subsets and B lymphocyte subsets), patient's pulmonary function, performance status scale(PS),self-rating scale of sleep(SRSS), and adverse events(AEs).DISCUSSION: The trial results can provide efficacy and safety data of Zhengyuan capsule when treating CRF in clinic. The data can also be imported into the management and treatment guidelines for CRF in lung cancer patients undergoing operation throughout China.展开更多
In Energy Harvesting Wireless Sensor Networks(EHWSN),the communication protocol will directly affect the final performance of the network,so it is necessary to study the communication protocol based on EHWSN.In this p...In Energy Harvesting Wireless Sensor Networks(EHWSN),the communication protocol will directly affect the final performance of the network,so it is necessary to study the communication protocol based on EHWSN.In this paper,for the low-cost fixed clustering problem,a fixed clustering protocol RRCEH is based on random relaying.Our proposed RRCEH abandons the inefficient inter-cluster communication method of the traditional fixed clustering protocol.To coordinate the data upload of the cluster head,RRCEH allocates different random relay vectors to each ring area of the network,and combines all the random relay vectors into a random relay matrix of RRCEH.In each communication round,the cluster head node randomly selects its relay target node to send data according to the probability distribution in the random relay vector in the area.For two different cluster head configuration scenarios,by optimizing the random relay matrix,RRCEH can effectively reduce the network's configuration requirements for cluster head energy harvesting capability,thus reducing the deployment cost of EHWSN.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： Allergic rhinitis（AR） is defined as an immunoglobulin led atopic disorder that affects the nasal mucosa. Moxibustion on herbs, a common complementary and alternative medicine approach, is frequently use...Background： Allergic rhinitis（AR） is defined as an immunoglobulin led atopic disorder that affects the nasal mucosa. Moxibustion on herbs, a common complementary and alternative medicine approach, is frequently used for treating AR in clinical practice. Western medicine is good at quick symptomatic relief,while offer little or no sustainable and steady long-term effect. Little established evidence is available to support the long-term effectiveness of moxibustion on herbs for AR.Objective： This study is a randomized controlled trial to assess the long-term effectiveness of moxibustion on herbs in moderate-severe persistent AR population.Methods： The study sample size is 56 patients. Eligible patients with moderate-severe persistent AR will be randomized into a moxibustion on herbs combined with conventional treatment group（MOHCT group） and a conventional treatment group（CT group） in a 1：1 ratio. Patients in the MOHCT group will receive a 30-min moxibustion on herbs treatment on Zhiyang（至阳 GV 9）, Dàzhuī（大椎 GV 14） and bilateral Shenshu（肾俞 BL 23）, Fèishū（肺俞 BL 13） for a total of 12 times on the basis of conventional treatment, while those in the CT group will receive conventional treatment alone. The primary outcome measure is VAS score for total nasal symptoms, which will be obtained via a self-recorded AR diary. The secondary outcome measures include the average occurrence of symptoms per week, use of medication and Rhinoconjunctivitis Quality of Life Questionnaire（RQLQ）.Discussion： The objectives of this study include（1） to evaluate the long-term effectiveness and safety of moxibustion on herbs for treating AR;（2） to evaluate whether moxibustion on herbs can reduce the frequency of AR symptoms in patients with moderate-severe persistent allergic rhinitis. The finding of this study will provide evidence on the long-term effectiveness of moxibustion on herbs for moderatesevere persistent AR.展开更多
This study is to investigate the effectiveness and safety of bloodletting puncture(BP)for acute ischemic stroke(AIS)when used in combination with standard treatment,as well as the patients'feelings and attitudes t...This study is to investigate the effectiveness and safety of bloodletting puncture(BP)for acute ischemic stroke(AIS)when used in combination with standard treatment,as well as the patients'feelings and attitudes toward the treatment.This is a mixed method research which includes a multi-center,superiority,randomized controlled clinical trial,and focus group interview.A total of 360 AIS participants will be enrolled.They will be randomized into one of the following two groups for 7 d:(a)BP with standard treatment group(n=180);(b)standard treatment group(n=180).The primary outcome will be National Institute of Health stroke scale(NIHSS)score at day 7 after treatment.Secondary outcomes will be changes of Glasgow Coma Scale score,NIHSS score,mRS and Traditional Chinese Medicine syndrome score from baseline to 7,14,and 30 d after treatment,recurrence rate and all-cause mortality rate within 30 d,and the safety assessments.The focus group will be conducted with a purposive sample of 1-2 acupuncturists and 1-2 patients respectively at each center at 7 and 30 d after treatment.We designed a mixed method study to evaluate the effect of BP,an acupuncture therapy for patients with AIS.If the findings of this study confirm the effectiveness of BP to reduce the NIHSS score and other related outcomes and patients are willing to accept the therapy,we believe this study will help the implementation of this therapy in clinical practice,and provide new evidence for the treatment of AIS.展开更多
OBJECTIVE:To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm(CHEP)formula and tonifying Qi and activating blood circulation(TQABC)form...OBJECTIVE:To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm(CHEP)formula and tonifying Qi and activating blood circulation(TQABC)formula in patients with acute ischemic stroke(AIS)within a 72 h time window.METHODS:In this randomized,multicenter,doubleblinded,placebo-controlled trial,500 participants will be randomly assigned in a ratio of 1∶1 to the CHEP+TQABC group or control group.In addition to guidelinebased standard medical care,participants in the treatment group will receive the CHEP formula for the first 5 consecutive days followed by the TQABC formula for another 10 consecutive days,while those in the control group will receive CHEP formula placebo and TQABC formula placebo consecutively.The primary outcome measure will be the comparison of the change in the National Institutes of Health Stroke Scale score from baseline to 15 days after randomization.The secondary outcome measures will include the scores on the modified Rankin Scale,Barthel Index,Patient-Reported Outcomes,TCM symptom pattern(Zheng-hou)evaluation Scale,and the incidence of in-hospital complications.Safety assessment will include the physical examination,laboratory detection,any adverse events or serious adverse events,and the proportion of any complications during hospitalization.DISCUSSION:The results of this study will provide objective and scientific data with which to assess the efficacy and safety of a sequential treatment based on“integrating disease and symptom pattern”for patients with AIS.展开更多
Objective:This trial is aimed at evaluating the efficacy and safety of acupuncture on treating FC.Methods:We describe the protocol for a randomized,patient-assessor-blinded,sham controlled trial.Seventy-two eligible p...Objective:This trial is aimed at evaluating the efficacy and safety of acupuncture on treating FC.Methods:We describe the protocol for a randomized,patient-assessor-blinded,sham controlled trial.Seventy-two eligible patients will be randomly assigned to the intervention group(acupuncture)or the control group(sham acupuncture).All treatment will be given 26 sessions of acupuncture or sham acupuncture over 8 weeks(5 times per week in the first 2 weeks,3 times per week during weeks 3-6,and 2 times per week during weeks 7 and 8).Each treatment will last for 20 min.The primary outcome is the change in mean complete spontaneous bowel movements(CSBMs)per week.The secondary out?comes are patient assessment of constipation quality of life questionnaire(PAC-QOL),self-rating anxiety scale(SAS),and the dosage of the medication.All adverse events will be recorded in detail and managed by corresponding researchers as quickly as possible.Outcomes will be evaluated at baseline(1 week before treatment),2 weeks after intervention begins,6 weeks after intervention begins,8 weeks after intervention begins,4 weeks follow-up,and 12 weeks follow-up.Discussion:The results of this study will provide the evidence of the efficacy and safety of acupuncture as a traditional treatment methods for functional constipation.Trial registration:Chinese Clinical Trial Registry,ChiCTR-INR-17011472.Registered on 23 May 2017.展开更多
Demand assignment MAC protocols have been used widely in wireless networks. It can effectively utilize wireless bandwidth. Some strategies can he used by demand assignment MAC protocols to further improve their effici...Demand assignment MAC protocols have been used widely in wireless networks. It can effectively utilize wireless bandwidth. Some strategies can he used by demand assignment MAC protocols to further improve their efficiency. The concept of transmit probability is introduced. This concept allows a request slot to be assigned to many different traffic classes at the same time. Based on it, the dynamic random channel reservation （DRCR） protocol is proposed. The DRCR protocol operates dynamically by observing the traffic conditions. It uses information about the recent traffic conditions to assign transmit probability with which an mobile station can select request slots with lower traffic. The performance of DRCR is evaluated and compared with RSCA. The results show that DRCR is more stable than RSCA, it offers shorter delays of requests than RSCA and can relieve heavily stressed traffic classes faster than RSCA.展开更多
基金supported by the Chinese Medicine Development Fund,Hong Kong SAR,China(23B2/027A_R1)the National Natural Science Foundation of China(81704198).
文摘Objective:To evaluate the efficacy and safety of acupoint application for post-stroke depression(PSD)by regulating gastrointestinal function.A secondary objective is to explore the potential mechanism underlying this approach from the perspective of gut microbiota.Methods:This multicenter,randomized,double-blind(patients and assessors),placebo-controlled trial will enroll 80 patients with PSD,and include a 1-week run-in period,a 4-week treatment phase,and a 12-week follow-up.Eligible participants will randomly be assigned in a 1:1 ratio to either the acupoint application or placebo(non-acupoint)groups.Treatments will be administered thrice weekly for 4 weeks.The primary outcome is change in the Hamilton Rating Scale for Depression(HAMD)score.Secondary outcomes include the Beck Depression Inventory(BDI),36-Item Short-Form Health Survey(SF-36),Barthel Index of Activities of Daily Living,Social Adaptation Self-Evaluation Scale(SASS),and gut microbiota profiling.All outcomes will be assessed at baseline(prior to treatment),during treatment(weeks 2 and 4),and during follow-up(weeks 8,12,and 16).The Treatment Emergent Symptom Scale(TESS)will be used for evaluation throughout the 4-week treatment phase.Discussion:The results of this study will provide important evidence supporting a novel treatment strategy for PSD that targets gastrointestinal regulation,potentially informing future clinical practice.
基金supported by a grant from the Science and Technology Planned Project of Sichuan Province,China (No.18YYJC0949)
文摘Background: Insomnia is a common complaint that is closely related to gastrointestinal symptoms, which is consistent with the traditional Chinese medicine classical theory of ‘‘stomach disharmony leading to restless sleep." Acupuncture is an effective complementary and alternative medicine therapy to improve gastrointestinal function and restore the normal sleep-wake cycle. However, studies on the effectiveness of acupuncture for insomnia due to spleen-stomach disharmony syndrome are limited to case reports and few randomized controlled trials; deeper research on its mechanism is still lacking. This randomized controlled trial aims to assess the treatment efficacy of ‘‘harmonizing stomach to tranquilize mind"acupuncture for insomnia and its influence on the intestinal microbiome.Methods/design: This is a randomized, single-blind, parallel-group study. Sixty eligible patients with insomnia due to spleen-stomach disharmony syndrome will be randomly divided into two groups(1:1 allocation ratio). The intervention group will use ‘‘harmonizing stomach to tranquilize mind"acupuncture, and the control group will receive sham acupuncture. Participants will receive 5 acupuncture treatment sessions per week for 4 consecutive weeks. The Pittsburgh Sleep Quality Index will be used to evaluate the clinical efficacy of acupuncture treatment by making assessments at baseline, the end of treatment and the end of the follow-up. High-throughput 16 S ribosomal ribonucleic acid gene sequencing will be performed to detect changes in the intestinal microbial composition before and after treatment.Discussion: The results of this trial are expected to confirm that ‘‘harmonizing stomach to tranquilize mind" acupuncture can effectively relieve insomnia and alter the intestinal microbiome.
基金funded by Science and Technology Commission of Shanghai Municipality(No.17401933900)
文摘Background: Fire-needle acupuncture, an important kind of acupuncture therapy, has been clinically used to treat upper limb spastic paralysis(ULSP) after stroke. Clinical experience has indicated that fire-needle acupuncture treatment takes less time, requires fewer visits, and has more rapid results and fewer side effects compared to chemical medicine alternatives. This study will evaluate the effects of fire-needle acupuncture for ULSP in the context of standardized clinical research and provide high-quality data to inform clinical procedures and future study design.Methods/Design: A randomized controlled trial will be carried out to evaluate the effects of fire-needle acupuncture therapy in patients with ULSP from stroke. ULSP patients(n = 120) will be recruited at Changhai Hospital in Shanghai, China. Patients will be randomly divided into three groups, including fire-needle acupuncture group(FAG), filiform-needle acupuncture group(FFAG) and rehabilitation treatment group(RTG). During the 3-week treatment, the FAG will be treated every two days, while FFAG and RTG will be treated 5 d in a row and then rest for 2 d. The Simplified Fugl-Meyer Motor Function Scale and Modified Ashworth Scale will be used as the primary outcome measures. Statistical analysis will be conducted by an independent statistician.Discussion: Through this study, the utility of fire-needle acupuncture in treating ULSP after stroke will be tested, and some specific claims of fire-needle acupuncture therapy will be evaluated, such as relieving spasm and muscular tension, improving activities of daily living, rapidity of response and less frequency of treatment compared with other treatments.
基金Supported by the National Science and Technology Pillar Program during the 12th Five-year Plan Period of the People's Republic of China:Heritage Study on the Special Therapeutic Principles and Methods of Famous Experts in Traditional Chinese Medicine(No.2013BAI13B022)
文摘OBJECTIVE: To investigate the efficacy and safety of Xinglouchengqi(XLCQ) decoction in treatment of acute ischemic stroke with constipation.METHODS: In this prospective, multicenter, assessor-blinded, randomized controlled trial, 360 eligible participants will be randomized to the XLCQ group or the control group. Participants in the XLCQ group will receive XLCQ decoction, while those in the control group will undergo clysis therapy using glycerin enemas or oral administration of lactulose solution. Both groups will undergo a treatment period of(5 ± 2) d and a 1-month follow-up.The primary outcome measure will be the Constipation Scale score. The secondary outcome measures will include scores on the National Institutes of Health Stroke Scale, the Traditional Chinese Medicine(TCM) Stroke Scale, the Diagnostic Scale for TCM Syndromes of Ischemic Stroke and TCM Scale for Syndrome of Phlegm-heat and Fu-organ Excess.Therapeutic mechanism outcomes and safety outcomes will also be assessed. Assessments will be conducted at baseline, at the end of the treatment period, and at the follow-up. Moreover, daily visits will be scheduled to grade the status of constipation during the treatment period.DISCUSSION: The results of this study will provide scientific and objective data with which to assess the efficacy and safety of XLCQ decoction for patients with acute ischemic stroke and constipation.
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.
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 the Twelfth Five-Year Support Project of the Ministry of Science and Technology for clinical studies investigating Xin'an medicine in the treatment of complicated ascites diseases(No.2012BAI26B02)
文摘BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.
基金Specific Research Funding for the Traditional Chinese Medicine Industry of State Administration of Traditional Chinese Medicine (No.200807052)
文摘BACKGROUND： Parkinson＇s disease （PD） is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its complex pathogenesis. Adverse effects from Western drug-based medical intervention prevent long-term adherence to these therapies in many patients. Traditional Chinese medicine （TCM） has long been used to improve the treatment of PD by alleviating the toxic and adverse effects of Western drug-based intervention. Therefore, the aim of this study is to evaluate the efficacy and safety of Xifeng Dingchan Pill （XFDCP）, a compound traditional Chinese herbal medicine, taken in conjunction with Western medicine in the treatment of PD patients at different stages in the progression of the disease. METHODS AND DESIGN： This is a multicenter, randomized controlled trial. In total, 320 patients with early- （n = 160） and middle-stage PD （n = 160） will be enrolled and divided evenly into control and trial groups. Of the 160 patients with early-stage PD, the trial group （n = 80） will be given XFDCP, and the control group （n = 80） will be given Madopar. Of the 160 patients with middle-stage PD, the trial group （n = 80） will be given XFDCP combined with Madopar and Piribedil, and the control group （n = 80） will be given Madopar and Piribedil. The Unified Parkinson＇s Disease Rating Scale scores, TCM symptoms scores, quality of life, change of Madopar＇s dosage and the toxic and adverse effects of Madopar will be observed during a 3-month treatment period and through a further 6-month follow-up period. DISCUSSION： It is hypothesized that XFDCP, combined with Madopar and Piribedil, will have beneficial effects on patients with PD. The results of this study will provide evidence for developing a comprehensive therapy regimen, which can delay the progress of the disease and improve the quality of life for PD patients in different stages. TRIAL REGISTRATION： This trial has been registered in the Chinese Clinical Trial Registry with the identifer ChiCTR-TRC-12002150.
基金Supported by Zhejiang Provincial Administration of Traditional Chinese Medicine:Herb-partitioned in Pelvic and Sacral Region for Endometriosis:a Randomized Contorlled Trial(No.2016ZQ022)National Key R&D Program of China:Innovative Research of Key Problems for Meridians Based on the Heart and Lung Meridians(No.2018YFC1704600)Zhejiang Province Top Discipline of Chinese Medicine(No.ZTK2017A02)。
文摘OBJECTIVE: To investigate the effect of herb-partitioned moxibustion(HPM) on pain and quality of life in women with endometriosis.METHODS: Thirty-six patients will be randomly assigned to a treatment group or a wait-list control group. The treatment group will receive 12 sessions of HPM in the lower abdomen and lumbosacral region for 3 months. Wait-list participants will not receive any specific treatments until the trial is completed.RESULTS: The primary outcome measure is pain intensity assessed by a Visual Analogue Scale at baseline, months 1, 2, and 3 in the treatment period,and months 4, 5, and 6 in the follow-up period. Secondary outcome measures include quality of life assessed by the Short Form 36 Health Survey, change in CA125, change in cyst diameter(assessed by ultrasound examination), and rescue medication dosage.CONCLUSION: This study will provide evidence to confirm if HPM may be used as a therapeutic option for treating endometriosis.
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.
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.
基金Supported by National Science and Technology Major Project Evaluation of Clinical Efficacy of Chinese Herbal Medicines in Reducing the Mortality of Acute-on-Chronic Liver Failure(No.2018ZX10725-506-002)。
文摘OBJECTIVE:To conduct a multicenter randomized controlled trial of the efficacy of standardized Chinese herbal medicines(CHMs)against acuteon-chronic liver failure(ACLF)and provide reproducible and high-level evidence for clinical practice.METHODS:This is a prospective,multicenter,centrally randomized controlled trial.Patients diagnosed with hepatitis B virus-related ACLF(n=510)will be allocated to the standard medical therapy or CHM group at a 1∶1 ratio.Two CHMs will be used on the basis of the traditional Chinese medicine syndrome:Liangxue Jiedu granules for excess syndromes and Yiqi Jiedu granules for deficiency syndromes.The primary outcome is transplant-free survival at week 12.The secondary outcomes are(a)transplant-free survival at week 24,(b)liver function as assessed using the model for end-stage liver disease score at week 12,(c)liver function as assessed using the Child-Pugh score at week 12,and(d)the incidence of complications at week 12.DISCUSSION:The effectiveness and safety of CHM formulations will be assessed following treatment for ACLF.TRIAL REGISTRATION:The trial was registered at Clinical Trials.gov(NCT03577938)on June 24,2018.
基金Supported by Development of Science and Technology of Guangdong Province Special Fund Project (No.2060502)the National Natural Science Foundation of China (No.81573893)the Shanghai Municipal Commission of Health and Family Planning Research Project (No.2018LP026)。
文摘OBJECTIVE: To evaluate the efficacy and safety of Zhengyuan capsule(正元胶囊) when treating Cancer-related fatigue(CRF) in lung cancer patients undergoing surgical operation.METHODS/DESIGN: This is a single-center, double-blinded, prospective, and randomized controlled trial in the Department of Integrated Chinese and Western Medicine, Shanghai Chest Hospital Shanghai Jiao Tong University, Shanghai. Eligible participants will be randomly allocated into two groups: a treatment group receiving an 8-week Zhengyuan capsule regimen therapy and a control group receiving an 8-week placebo capsule regimen therapy. Evaluation will be carried out at four timelines: the participants' screening period, baseline period, the middle of the intervention period,and the end of the intervention period. The primary outcome assessment is fatigue scoring using the Cancer Fatigue Scale(CFS) measurement system.Secondary measurements include fatigue severity assessment using the Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF) measurement system, Traditional Chinese Medicine syndrome pattern differentiation, levels of immunologic indicators(TNF-α, IL-6, IL-1, T lymphocytes subsets and B lymphocyte subsets), patient's pulmonary function, performance status scale(PS),self-rating scale of sleep(SRSS), and adverse events(AEs).DISCUSSION: The trial results can provide efficacy and safety data of Zhengyuan capsule when treating CRF in clinic. The data can also be imported into the management and treatment guidelines for CRF in lung cancer patients undergoing operation throughout China.
文摘In Energy Harvesting Wireless Sensor Networks(EHWSN),the communication protocol will directly affect the final performance of the network,so it is necessary to study the communication protocol based on EHWSN.In this paper,for the low-cost fixed clustering problem,a fixed clustering protocol RRCEH is based on random relaying.Our proposed RRCEH abandons the inefficient inter-cluster communication method of the traditional fixed clustering protocol.To coordinate the data upload of the cluster head,RRCEH allocates different random relay vectors to each ring area of the network,and combines all the random relay vectors into a random relay matrix of RRCEH.In each communication round,the cluster head node randomly selects its relay target node to send data according to the probability distribution in the random relay vector in the area.For two different cluster head configuration scenarios,by optimizing the random relay matrix,RRCEH can effectively reduce the network's configuration requirements for cluster head energy harvesting capability,thus reducing the deployment cost of EHWSN.
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Supported by the Natural Science Foundation of Beijing Municipality,China:No.7164272the Project of Development of Science and Technology of TCM of Beijing:No.JJ2015-62~~
文摘Background： Allergic rhinitis（AR） is defined as an immunoglobulin led atopic disorder that affects the nasal mucosa. Moxibustion on herbs, a common complementary and alternative medicine approach, is frequently used for treating AR in clinical practice. Western medicine is good at quick symptomatic relief,while offer little or no sustainable and steady long-term effect. Little established evidence is available to support the long-term effectiveness of moxibustion on herbs for AR.Objective： This study is a randomized controlled trial to assess the long-term effectiveness of moxibustion on herbs in moderate-severe persistent AR population.Methods： The study sample size is 56 patients. Eligible patients with moderate-severe persistent AR will be randomized into a moxibustion on herbs combined with conventional treatment group（MOHCT group） and a conventional treatment group（CT group） in a 1：1 ratio. Patients in the MOHCT group will receive a 30-min moxibustion on herbs treatment on Zhiyang（至阳 GV 9）, Dàzhuī（大椎 GV 14） and bilateral Shenshu（肾俞 BL 23）, Fèishū（肺俞 BL 13） for a total of 12 times on the basis of conventional treatment, while those in the CT group will receive conventional treatment alone. The primary outcome measure is VAS score for total nasal symptoms, which will be obtained via a self-recorded AR diary. The secondary outcome measures include the average occurrence of symptoms per week, use of medication and Rhinoconjunctivitis Quality of Life Questionnaire（RQLQ）.Discussion： The objectives of this study include（1） to evaluate the long-term effectiveness and safety of moxibustion on herbs for treating AR;（2） to evaluate whether moxibustion on herbs can reduce the frequency of AR symptoms in patients with moderate-severe persistent allergic rhinitis. The finding of this study will provide evidence on the long-term effectiveness of moxibustion on herbs for moderatesevere persistent AR.
基金Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences:Research Design and Application of Mixed Methods in Traditional Chinese Medicine (No.CI2021B003)Evidence-based Ability Construction Project of National Administration of Traditional Chinese Medicine:Evidencebased Ability Improvement and Platform Construction of Traditional Chinese Medicine in Encephalopathy (No.2019XZZX-NB014)+2 种基金CACMS Innovation Fund:Research Priorities on Screening and Evaluating Appropriate and Effective Health Technologies in Specific Disease Field of TCM (No.CI2021A05503)CACMS Innovation Fund:Evaluation Method and Demonstration Research of Traditional Chinese Medicine Health Technology Assessment (No.CI2021A00701-3)the Fundamental Research Funds for the Central Public Welfare Research Institutes:Evidence Mapping and Scoping Review of Chinese Patent Medicines for Clearing Heat and Detoxifying (No.ZZ13-YQ-075)
文摘This study is to investigate the effectiveness and safety of bloodletting puncture(BP)for acute ischemic stroke(AIS)when used in combination with standard treatment,as well as the patients'feelings and attitudes toward the treatment.This is a mixed method research which includes a multi-center,superiority,randomized controlled clinical trial,and focus group interview.A total of 360 AIS participants will be enrolled.They will be randomized into one of the following two groups for 7 d:(a)BP with standard treatment group(n=180);(b)standard treatment group(n=180).The primary outcome will be National Institute of Health stroke scale(NIHSS)score at day 7 after treatment.Secondary outcomes will be changes of Glasgow Coma Scale score,NIHSS score,mRS and Traditional Chinese Medicine syndrome score from baseline to 7,14,and 30 d after treatment,recurrence rate and all-cause mortality rate within 30 d,and the safety assessments.The focus group will be conducted with a purposive sample of 1-2 acupuncturists and 1-2 patients respectively at each center at 7 and 30 d after treatment.We designed a mixed method study to evaluate the effect of BP,an acupuncture therapy for patients with AIS.If the findings of this study confirm the effectiveness of BP to reduce the NIHSS score and other related outcomes and patients are willing to accept the therapy,we believe this study will help the implementation of this therapy in clinical practice,and provide new evidence for the treatment of AIS.
基金Supported by the National Key Research and Development Program of China(Evidence-based Evaluation of TCM Key Syndrome Differentiation and Treatment for Acute Ischemic Stroke,No.2018YFC1705002)
文摘OBJECTIVE:To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm(CHEP)formula and tonifying Qi and activating blood circulation(TQABC)formula in patients with acute ischemic stroke(AIS)within a 72 h time window.METHODS:In this randomized,multicenter,doubleblinded,placebo-controlled trial,500 participants will be randomly assigned in a ratio of 1∶1 to the CHEP+TQABC group or control group.In addition to guidelinebased standard medical care,participants in the treatment group will receive the CHEP formula for the first 5 consecutive days followed by the TQABC formula for another 10 consecutive days,while those in the control group will receive CHEP formula placebo and TQABC formula placebo consecutively.The primary outcome measure will be the comparison of the change in the National Institutes of Health Stroke Scale score from baseline to 15 days after randomization.The secondary outcome measures will include the scores on the modified Rankin Scale,Barthel Index,Patient-Reported Outcomes,TCM symptom pattern(Zheng-hou)evaluation Scale,and the incidence of in-hospital complications.Safety assessment will include the physical examination,laboratory detection,any adverse events or serious adverse events,and the proportion of any complications during hospitalization.DISCUSSION:The results of this study will provide objective and scientific data with which to assess the efficacy and safety of a sequential treatment based on“integrating disease and symptom pattern”for patients with AIS.
基金supported by the Shanghai Municipal Commission of Health and Family Planning(Grant No.2016LQ015)
文摘Objective:This trial is aimed at evaluating the efficacy and safety of acupuncture on treating FC.Methods:We describe the protocol for a randomized,patient-assessor-blinded,sham controlled trial.Seventy-two eligible patients will be randomly assigned to the intervention group(acupuncture)or the control group(sham acupuncture).All treatment will be given 26 sessions of acupuncture or sham acupuncture over 8 weeks(5 times per week in the first 2 weeks,3 times per week during weeks 3-6,and 2 times per week during weeks 7 and 8).Each treatment will last for 20 min.The primary outcome is the change in mean complete spontaneous bowel movements(CSBMs)per week.The secondary out?comes are patient assessment of constipation quality of life questionnaire(PAC-QOL),self-rating anxiety scale(SAS),and the dosage of the medication.All adverse events will be recorded in detail and managed by corresponding researchers as quickly as possible.Outcomes will be evaluated at baseline(1 week before treatment),2 weeks after intervention begins,6 weeks after intervention begins,8 weeks after intervention begins,4 weeks follow-up,and 12 weeks follow-up.Discussion:The results of this study will provide the evidence of the efficacy and safety of acupuncture as a traditional treatment methods for functional constipation.Trial registration:Chinese Clinical Trial Registry,ChiCTR-INR-17011472.Registered on 23 May 2017.
文摘Demand assignment MAC protocols have been used widely in wireless networks. It can effectively utilize wireless bandwidth. Some strategies can he used by demand assignment MAC protocols to further improve their efficiency. The concept of transmit probability is introduced. This concept allows a request slot to be assigned to many different traffic classes at the same time. Based on it, the dynamic random channel reservation （DRCR） protocol is proposed. The DRCR protocol operates dynamically by observing the traffic conditions. It uses information about the recent traffic conditions to assign transmit probability with which an mobile station can select request slots with lower traffic. The performance of DRCR is evaluated and compared with RSCA. The results show that DRCR is more stable than RSCA, it offers shorter delays of requests than RSCA and can relieve heavily stressed traffic classes faster than RSCA.
