scholarly journals Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology: application to a randomized controlled acupuncture trial

2011 ◽  
Vol 31 (7) ◽  
pp. 619-627 ◽  
Author(s):  
Lixing Lao ◽  
Yi Huang ◽  
Chiguang Feng ◽  
Brian M. Berman ◽  
Ming T. Tan
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Statistical Methodology ◽  
Randomized Controlled

scholarly journals Baidu Jieduan granule, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

2020 ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granule in treatment of moderate COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

Efficacy and Safety of Traditional Chinese Medicine in COVID-2019: A Study Protocol for an Open-Label, Multicenter Randomized Controlled Trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Zhengzhong Yuan ◽  
Xiaoqiong Pan ◽  
Jizhou Zhang ◽  
Jiahui Zhu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Measures ◽  
Lung Injury Score ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Introduction: The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. It directly leads to high morbidity and mortality, but also results in a devastating effect on the global economy. Unfortunately, there are no effective therapies or vaccines for it. Hence, we designed a randomized trial to evaluate the efficacy and safety of Traditional Chinese Medicine for treating patients with COVID-19.Methods and analysis: This is an open-label, multicenter randomized controlled clinical trial. One hundred and twelve patients infected by SARS-CoV-2 will be randomly assigned to the experimental or the control group in an equal ratio. The patients in control group will accept routine supportive clinically care including the therapies of anti-viral, anti-bacterial and ameliorating the related symptoms, while patients in the experimental group will be asked to take traditional Chinese medicine depending on the different stages of the disease for consecutive 14 days in addition to supportive care. All data will be gathered at baseline and on days 3, 7, 10 and 14. The primary outcome measures will be the time of Reverse Transcription PCR testing of respiratory tract sample turns to be negative. Secondary outcome measures will include Murray lung injury score, MuLBSTA score and TCM ( Traditional Chinese Medicine ) Syndrome Scoring System. A laboratory test will be taken before and after treatment to assess the safety of TCM.Discussion: The study may help to identify the the efficacy and safety of Traditional Chinese Medicine in treating COVID-2019.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000030759.Registered on March 13th 2020-Retrospectively registered, http://www.chictr.org.cn/.

scholarly journals Efficacy of the combination of modern medicine and traditional Chinese medicine in pulmonary fibrosis arising as a sequelae in convalescent COVID-19 patients: a randomized multicenter trial

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Zhen-Hui Lu ◽  
Chun-Li Yang ◽  
Gai-Ge Yang ◽  
Wen-Xu Pan ◽  
Li-Guang Tian ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Lung Function ◽  
Pulmonary Fibrosis ◽  
Modern Medicine ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background The coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has led to a significant number of mortalities worldwide. COVID-19 poses a serious threat to human life. The clinical manifestations of COVID-19 are diverse and severe and 20% of infected patients are reported to be in a critical condition. A loss in lung function and pulmonary fibrosis are the main manifestations of patients with the severe form of the disease. The lung function is affected, even after recovery, thereby greatly affecting the psychology and well-being of patients, and significantly reducing their quality of life. Methods Participants must meet the following simultaneous inclusion criteria: over 18 years of age, should have recovered from severe or critical COVID-19 cases, should exhibit pulmonary fibrosis after recovery, and should exhibit Qi-Yin deficiency syndrome as indicated in the system of traditional Chinese medicine (TCM). The eligible candidates will be randomized into treatment or control groups. The treatment group will receive modern medicine (pirfenidone) plus TCM whereas the control group will be administered modern medicine plus TCM placebo. The lung function index will be continuously surveyed and recorded. By comparing the treatment effect between the two groups, the study intend to explore whether TCM can improve the effectiveness of modern medicine in patients with pulmonary fibrosis arising as a sequelae after SARS-CoV-2 infection. Discussion Pulmonary fibrosis is one of fatal sequelae for some severe or critical COVID-19 cases, some studies reveal that pirfenidone lead to a delay in the decline of forced expiratory vital capacity, thereby reducing the mortality partly. Additionally, although TCM has been proven to be efficacious in treating pulmonary fibrosis, its role in treating pulmonary fibrosis related COVID-19 has not been explored. Hence, a multicenter, parallel-group, randomized controlled, interventional, prospective clinical trial has been designed and will be conducted to determine if a new comprehensive treatment for pulmonary fibrosis related to COVID-19 is feasible and if it can improve the quality of life of patients. Trial registration: This multicenter, parallel-group, randomized controlled, interventional, prospective trial was registered at the Chinese Clinical Trial Registry (ChiCTR2000033284) on 26th May 2020 (prospective registered).

scholarly journals Herbal medicine (Danggui-Shaoyao-San) and Ear Acupoint Pressing Beans in the treatment of dysmenorrhea caused by endometriosis and adenomyosis: a study protocol randomized controlled trial

2019 ◽  
Author(s):  
Yingzhou Tian ◽  
Jiayi Wu ◽  
Yanxiong Huang ◽  
Xuefang Liang ◽  
Lixing Cao
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Short Form ◽  
Controlled Trial ◽  
International Standards ◽  
Mcgill Pain Questionnaire ◽  
Menstrual Pain ◽  
Randomized Controlled

Abstract Endometriosis and adenomyosis are two of the most common causes of secondary dysmenorrhea and often lead to a deterioration in the quality of life. Traditional Chinese medicine and acupuncture are widely used in the treatment of menstrual pain in clinical practice. Danggui Shaoyao San (DSS) and ear acupoint pressing beans may constitute an effective treatment strategy for women with dysmenorrhea due to endometriosis and/or adenomyosis, although evidence is limited. Methods/design This randomized, controlled clinical trial aims to recruit patients who suffer from menstrual pain due to endometriosis and/or adenomyosis to evaluate the efficacy and safety of DSS and auriculotherapy. Primary outcome measures are Visual Analog Scale (VAS), Short-Form McGill Pain Questionnaire (SF-MPQ), dysmenorrhea symptoms and traditional Chinese medicine correlative time points. Discussion This pivotal trial will be a standardized, scientific, clinical trial designed to evaluate the use of DSS and auriculotherapy in the treatment of dysmenorrhea due to endometriosis and/or adenomyosis. The trial will also conform to the international standards of clinical trials for the recognition of traditional Chinese medicine. Trail registration Chinese Clinical Trail Registry, ID: ChiCTR-IOR-17013829 Registered on 11th December 2017 Keywords: Danggui Shaoyao San; Ear pressing beans; Endometriosis; Adenomyosis; Dysmenorrhea; Randomized controlled trial

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