Primary liver cancer(PLC) is the third major cause of cancer related death, which seriously affects the survival period and quality of life of patients. However, there is currently no evidence to prove which treatment...Primary liver cancer(PLC) is the third major cause of cancer related death, which seriously affects the survival period and quality of life of patients. However, there is currently no evidence to prove which treatment method is most effective. Traditional Chinese Medicine(TCM) has shown certain advantages in the treatment of PLC, especially in the side effects of Western Medicine. Therefore, we designed a clinical trial protocol for the treatment of PLC using TCM granules. Our purpose is to explore the efficacy and safety of Yangxiao Fukang granule(YXFKG, 养消复康颗粒) in the treatment of stage Ⅲ hepatitis B related PLC. A total of 216 patients from three hospitals in Henan Province will be enrolled and randomly divided into a trial group and a control group in a 1 ∶ 1 ratio. The trial group will be treated with conventional western medicine plus YXFKG, while the control group will receive conventional western medicine plus a placebo for YXFKG. All patients will receive a daily dose of either YXFKG or a placebo for six months, followed by a six-month follow-up period. The main observation outcome includes 1-year survival rate, while secondary outcomes include conversion rate to remission, objective response rate, progression free survival, overall survival, quality of life score, and TCM clinical symptom score. Blood routine, urine routine, stool routine, electrocardiogram, liver and kidney function, coagulation function test, and D-dimer are safety indicators. Collect data before treatment and during the 3rd, 6th, 9th, and 12th months of treatment, and conduct statistical analysis. This study will preliminarily verify the effectiveness and safety of YXFKG in the treatment of stage Ⅲ hepatitis B related PLC, which may provide a new choice for clinical treatment of PLC.展开更多
This pilot study is to assess the feasibility and the effect of a combination therapy of rehabilitation treatment and contralateral needling,which is manipulated at the foot of the unaffected side,for the recovery of ...This pilot study is to assess the feasibility and the effect of a combination therapy of rehabilitation treatment and contralateral needling,which is manipulated at the foot of the unaffected side,for the recovery of the paretic hand post-stroke.This prospective pilot clinical trial will recruit 72 stroke patients with paretic hands and a disease course of 14 to 90 d.Patients will be randomized into two groups:the control group will receive conventional Xingnao Kaiqiao acupuncture and basic treatment for the stroke;based on the control group,the observation group will receive the contralateral needling at the foot of the unaffected side combined with the rehabilitation movement of the paretic hand.12 sessions will be administrated for 2 weeks.The primary outcome,FuglMeyer Assessment,and the secondary outcomes,the handgrip strength,the range of motion,the modified Barthel index,and the Brunnstrom recovery stages,will be measured the recovery of the hand motor function during the 2 weeks'intervention.This study aims to investigate the instant effect of contralateral needling at the foot of the unaffected side combined with the rehabilitation treatment movement for patients with the paretic hand of Poststroke motor dysfunction and provide the previous evidence for the future large sample studies.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
OBJECTIVE: To observe the curative effect of Jinye Baidu granule in the treatment of fever and swollen and sore throat caused by wind-warmth lung-heat disease(heat in the lung-wei) to further identify the indications....OBJECTIVE: To observe the curative effect of Jinye Baidu granule in the treatment of fever and swollen and sore throat caused by wind-warmth lung-heat disease(heat in the lung-wei) to further identify the indications.METHODS: This randomized, double-blind, parallel, controlled trial will include patients with acute upper respiratory infection and wind-warmth lung-heat disease(heat in the lung-wei). Patientswith serious bacterial infection(white blood cell count > 12 × 10~9, neutrophils > 80%) will be excluded. Patients will be divided into three categories(blocks) according to their condition: fever only, a swollen and sore throat, and combined fever plus a swollen and sore throat. Patients within each of the three blocks will be further divided into a treatment group and a control group via stratified blocked randomization. The treatment group will be treated with Jinye Baidu granule, and the control group will be treated with Fufang Shuanghua granule. The primary outcome measure will be body temperature recovery time for patients with fever, throat symptom score for patients with a swollen and sore throat, and body temperature recovery time and throat symptom score for patients with combined fever plus a swollen and sore throat. Routine blood testing, urine testing, liver function, kidney function and ECG data of all patients will be collected as safety indices before and after enrollment, and adverse events will be recorded during the whole trial course.CONCLUSION: This study protocol will include stratified block analysis according to patients' symptoms, and identify the accurate clinical indications of Jinye Baidu granule. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment.展开更多
OBJECTIVE:To describe a protocol to assess the effects of Traditional Chinese Medicine(TCM)on patients with coronary heart disease(CHD)showing symptoms of phlegm-heat-stasis symptom pattern.METHODS:This is a single-bl...OBJECTIVE:To describe a protocol to assess the effects of Traditional Chinese Medicine(TCM)on patients with coronary heart disease(CHD)showing symptoms of phlegm-heat-stasis symptom pattern.METHODS:This is a single-blind randomized controlled trial that will be conducted in the First Teaching Hospital of Tianjin University of TCM and 60 patients with CHD showing phlegm-heat-stasis symptom pattern will be included.Patients will be randomly divided into either a treatment group(Qingre Huatan formulae+Western Medicine)or to acontrol group(conventional Western Medicine only)for 7-14 d.Primary patient outcomes will be vascular endothelial function and quality of life.Measurement data will be expressed as mean±standard deviation using t-test analysis or repeated-measure variance analysis.Enumeration data will be expressed by cases and percentages,usingχ^(2) analysis,and rank sum test will be used for ranked data.RESULTS:This study further verified the effectiveness and safety of Qingre Huatan formulae for the phlegm-heat-stasis syndrome pattern of CHD on the basis of previous studies on the characteristics of syndromes and medication rules.DISCUSSION:Phlegm-heat-stasis symptom pattern has become a common manifestation in CHD.Standardized Western medications together with TCM have been extensively used in China and have developed into a comprehensive treatment model.Our trial will help formulate recommendations for symptom maintenance and provide clinical evidence for the application of TCM for patients with CHD showing phlegm-heat-stasis symptom pattern.展开更多
BACKGROUND Gambling disorder is characterized by excessive and recurrent gambling and can have serious negative social consequences.Although several psychotherapeutic and pharmacological approaches have been used to t...BACKGROUND Gambling disorder is characterized by excessive and recurrent gambling and can have serious negative social consequences.Although several psychotherapeutic and pharmacological approaches have been used to treat gambling disorder,new treatment strategies are needed.Growing evidence suggests that dopamine D3 receptor plays a specific role in the brain reward system.AIM To investigate if blonanserin,a dopamine D3 receptor antagonist,would be effective in reducing gambling impulses in patients with gambling disorder.METHODS We developed a study protocol to measure the efficacy and safety of blonanserin as a potential drug for gambling disorder,in which up to 12 mg/d of blonanserin was prescribed for 8 wk.RESULTS A 37-year-old female patient with gambling disorder,intellectual disability,and other physical diseases participated in the pilot study.The case showed improvement of gambling symptoms without any psychotherapy.However,blonanserin was discontinued owing to excessive saliva production.CONCLUSION This case suggests that blonanserin is potentially an effective treatment for patients with gambling disorder who resist standard therapies,but it also carries a risk of adverse effects. Further studies are needed to confirm the findings.展开更多
Background Antiviral therapy can lead to regression of fibrosis in chronic hepatitis B(CHB),but it has a limited effect on cirrhosis.Chinese medicines(CMs),particularly Fuzheng Huayu Tablet(扶正化瘀片,FZHY),have an an...Background Antiviral therapy can lead to regression of fibrosis in chronic hepatitis B(CHB),but it has a limited effect on cirrhosis.Chinese medicines(CMs),particularly Fuzheng Huayu Tablet(扶正化瘀片,FZHY),have an antifibrotic effect in patients with CHB.Objective To observe the safety and efficacy of adjunctive FZHY in patients with hepatitis B virus(HBV)cirrhosis,this study was designed as a randomized,placebo-controlled,double-blind,parallel assignment,multicenter trial at 20 centers in China.The total 700 naive patients will be enrolled with compensate cirrhosis due to HBV,and randomly assigned into 2 groups,receiving entecavir(0.5 mg,daily)and FZHY placebo(1.6 g,3 times a day),or entecavir(0.5 mg,daily)and FZHY(1.6 g,3 times a day),respectively.The primary endpoint was histological improvement at week 48.The secondary outcome is the decline values of liver fibrosis using the noninvasive methods from baseline to week 48 in each arm of the study.Adverse events such as stomach upset,headache,fatigue,dizziness,nausea will be strictly recorded.Discussion Through this study,we hope to generate a solid evidence for the therapeutic strategy of HBV cirrhosis with a combination of anti-viral such as ETV and anti-fibrotic herbal product such as FZHY.Protocol version:Version 1.3,Date:2014.12.4.Trial registration number:NCT02241590.展开更多
Coronavirus disease 2019(COVID-19)is a newly emerging infectious disease.After its outbreak,researchers started a large number of clinical interventional studies,using a variety of interventions to study the different...Coronavirus disease 2019(COVID-19)is a newly emerging infectious disease.After its outbreak,researchers started a large number of clinical interventional studies,using a variety of interventions to study the different types of COVID-19 cases.In this article,we searched the websites of Chinese Clinical Trial Registry,Clinical Trials.gov,etc.,to study the publicly registered research information.Through the classification and summary of interventional methods,evaluation indicators,research design,etc.,this article provided readers with the outline of clinical research about COVID-19,and looked forward to the scientificity,feasibility,and future evidence of the clinical researches.展开更多
基金Supported by Henan Provincial Department of Science and Technology Project:Clinical Study on Yangxiao Fukang granule in the Treatment of StageⅢhepatitis B related Liver Cancer(232102310188)Henan Province Characteristic Backbone Discipline Construction Project:Guidelines for Traditional Chinese Medicine Diagnosis and Treatment of Hepatocellular Carcinoma after Hepatic Arterial Chemotherapy and Embolization(STG-ZYX03-202126)。
文摘Primary liver cancer(PLC) is the third major cause of cancer related death, which seriously affects the survival period and quality of life of patients. However, there is currently no evidence to prove which treatment method is most effective. Traditional Chinese Medicine(TCM) has shown certain advantages in the treatment of PLC, especially in the side effects of Western Medicine. Therefore, we designed a clinical trial protocol for the treatment of PLC using TCM granules. Our purpose is to explore the efficacy and safety of Yangxiao Fukang granule(YXFKG, 养消复康颗粒) in the treatment of stage Ⅲ hepatitis B related PLC. A total of 216 patients from three hospitals in Henan Province will be enrolled and randomly divided into a trial group and a control group in a 1 ∶ 1 ratio. The trial group will be treated with conventional western medicine plus YXFKG, while the control group will receive conventional western medicine plus a placebo for YXFKG. All patients will receive a daily dose of either YXFKG or a placebo for six months, followed by a six-month follow-up period. The main observation outcome includes 1-year survival rate, while secondary outcomes include conversion rate to remission, objective response rate, progression free survival, overall survival, quality of life score, and TCM clinical symptom score. Blood routine, urine routine, stool routine, electrocardiogram, liver and kidney function, coagulation function test, and D-dimer are safety indicators. Collect data before treatment and during the 3rd, 6th, 9th, and 12th months of treatment, and conduct statistical analysis. This study will preliminarily verify the effectiveness and safety of YXFKG in the treatment of stage Ⅲ hepatitis B related PLC, which may provide a new choice for clinical treatment of PLC.
基金the Exploration and Innovation Project from the First Teaching Hospital of Tianjin University of TCM(201921)。
文摘This pilot study is to assess the feasibility and the effect of a combination therapy of rehabilitation treatment and contralateral needling,which is manipulated at the foot of the unaffected side,for the recovery of the paretic hand post-stroke.This prospective pilot clinical trial will recruit 72 stroke patients with paretic hands and a disease course of 14 to 90 d.Patients will be randomized into two groups:the control group will receive conventional Xingnao Kaiqiao acupuncture and basic treatment for the stroke;based on the control group,the observation group will receive the contralateral needling at the foot of the unaffected side combined with the rehabilitation movement of the paretic hand.12 sessions will be administrated for 2 weeks.The primary outcome,FuglMeyer Assessment,and the secondary outcomes,the handgrip strength,the range of motion,the modified Barthel index,and the Brunnstrom recovery stages,will be measured the recovery of the hand motor function during the 2 weeks'intervention.This study aims to investigate the instant effect of contralateral needling at the foot of the unaffected side combined with the rehabilitation treatment movement for patients with the paretic hand of Poststroke motor dysfunction and provide the previous evidence for the future large sample studies.
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.
基金Supported by the Ninth Scientific Research Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(No.Z0406)the Research Project of World Federation of Chinese Medicine Societies(SCEPCM12E001)the Special Research Project of Traditional Chinese Medicines by the State Administration of Traditional Chinese Medicine(No.201507003-8)
文摘OBJECTIVE: To observe the curative effect of Jinye Baidu granule in the treatment of fever and swollen and sore throat caused by wind-warmth lung-heat disease(heat in the lung-wei) to further identify the indications.METHODS: This randomized, double-blind, parallel, controlled trial will include patients with acute upper respiratory infection and wind-warmth lung-heat disease(heat in the lung-wei). Patientswith serious bacterial infection(white blood cell count > 12 × 10~9, neutrophils > 80%) will be excluded. Patients will be divided into three categories(blocks) according to their condition: fever only, a swollen and sore throat, and combined fever plus a swollen and sore throat. Patients within each of the three blocks will be further divided into a treatment group and a control group via stratified blocked randomization. The treatment group will be treated with Jinye Baidu granule, and the control group will be treated with Fufang Shuanghua granule. The primary outcome measure will be body temperature recovery time for patients with fever, throat symptom score for patients with a swollen and sore throat, and body temperature recovery time and throat symptom score for patients with combined fever plus a swollen and sore throat. Routine blood testing, urine testing, liver function, kidney function and ECG data of all patients will be collected as safety indices before and after enrollment, and adverse events will be recorded during the whole trial course.CONCLUSION: This study protocol will include stratified block analysis according to patients' symptoms, and identify the accurate clinical indications of Jinye Baidu granule. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment.
基金Supported by the National Administration of Traditional Chinese Medicine,Research Project for Practice Development of National Traditional Chinese Medicine Clinical Research Bases:the effects of Traditional Chinese Medicine on Vascular Endothelial Function and Quality of Life in coronary heart disease showing phlegm-heat-stasis symptom pattern(No.JDZX2015003)。
文摘OBJECTIVE:To describe a protocol to assess the effects of Traditional Chinese Medicine(TCM)on patients with coronary heart disease(CHD)showing symptoms of phlegm-heat-stasis symptom pattern.METHODS:This is a single-blind randomized controlled trial that will be conducted in the First Teaching Hospital of Tianjin University of TCM and 60 patients with CHD showing phlegm-heat-stasis symptom pattern will be included.Patients will be randomly divided into either a treatment group(Qingre Huatan formulae+Western Medicine)or to acontrol group(conventional Western Medicine only)for 7-14 d.Primary patient outcomes will be vascular endothelial function and quality of life.Measurement data will be expressed as mean±standard deviation using t-test analysis or repeated-measure variance analysis.Enumeration data will be expressed by cases and percentages,usingχ^(2) analysis,and rank sum test will be used for ranked data.RESULTS:This study further verified the effectiveness and safety of Qingre Huatan formulae for the phlegm-heat-stasis syndrome pattern of CHD on the basis of previous studies on the characteristics of syndromes and medication rules.DISCUSSION:Phlegm-heat-stasis symptom pattern has become a common manifestation in CHD.Standardized Western medications together with TCM have been extensively used in China and have developed into a comprehensive treatment model.Our trial will help formulate recommendations for symptom maintenance and provide clinical evidence for the application of TCM for patients with CHD showing phlegm-heat-stasis symptom pattern.
基金Supported by The Grant from Council for Addiction Behavior Studies。
文摘BACKGROUND Gambling disorder is characterized by excessive and recurrent gambling and can have serious negative social consequences.Although several psychotherapeutic and pharmacological approaches have been used to treat gambling disorder,new treatment strategies are needed.Growing evidence suggests that dopamine D3 receptor plays a specific role in the brain reward system.AIM To investigate if blonanserin,a dopamine D3 receptor antagonist,would be effective in reducing gambling impulses in patients with gambling disorder.METHODS We developed a study protocol to measure the efficacy and safety of blonanserin as a potential drug for gambling disorder,in which up to 12 mg/d of blonanserin was prescribed for 8 wk.RESULTS A 37-year-old female patient with gambling disorder,intellectual disability,and other physical diseases participated in the pilot study.The case showed improvement of gambling symptoms without any psychotherapy.However,blonanserin was discontinued owing to excessive saliva production.CONCLUSION This case suggests that blonanserin is potentially an effective treatment for patients with gambling disorder who resist standard therapies,but it also carries a risk of adverse effects. Further studies are needed to confirm the findings.
基金Supported by Ministry of Science and Technology of the People’s Republic of China(No.2014ZX10005001)。
文摘Background Antiviral therapy can lead to regression of fibrosis in chronic hepatitis B(CHB),but it has a limited effect on cirrhosis.Chinese medicines(CMs),particularly Fuzheng Huayu Tablet(扶正化瘀片,FZHY),have an antifibrotic effect in patients with CHB.Objective To observe the safety and efficacy of adjunctive FZHY in patients with hepatitis B virus(HBV)cirrhosis,this study was designed as a randomized,placebo-controlled,double-blind,parallel assignment,multicenter trial at 20 centers in China.The total 700 naive patients will be enrolled with compensate cirrhosis due to HBV,and randomly assigned into 2 groups,receiving entecavir(0.5 mg,daily)and FZHY placebo(1.6 g,3 times a day),or entecavir(0.5 mg,daily)and FZHY(1.6 g,3 times a day),respectively.The primary endpoint was histological improvement at week 48.The secondary outcome is the decline values of liver fibrosis using the noninvasive methods from baseline to week 48 in each arm of the study.Adverse events such as stomach upset,headache,fatigue,dizziness,nausea will be strictly recorded.Discussion Through this study,we hope to generate a solid evidence for the therapeutic strategy of HBV cirrhosis with a combination of anti-viral such as ETV and anti-fibrotic herbal product such as FZHY.Protocol version:Version 1.3,Date:2014.12.4.Trial registration number:NCT02241590.
基金supported by the National Major Scientific Research Project(2017ZX10305501)。
文摘Coronavirus disease 2019(COVID-19)is a newly emerging infectious disease.After its outbreak,researchers started a large number of clinical interventional studies,using a variety of interventions to study the different types of COVID-19 cases.In this article,we searched the websites of Chinese Clinical Trial Registry,Clinical Trials.gov,etc.,to study the publicly registered research information.Through the classification and summary of interventional methods,evaluation indicators,research design,etc.,this article provided readers with the outline of clinical research about COVID-19,and looked forward to the scientificity,feasibility,and future evidence of the clinical researches.
