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  1. Article ; Online: Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome

    Pan-pan Tian / Qing-juan Wu / Jun Li / Heng-wen Chen / Ji Wu / Ya-wen Deng / Zi-cong Xie / Wei Zhao / Yu-qing Tan

    Trials, Vol 22, Iss 1, Pp 1-

    study protocol for a randomized controlled trial

    2021  Volume 8

    Abstract: Abstract Introduction Unstable angina pectoris (UAP) is the common type of coronary heart disease with the risk of developing into acute myocardial infarction (AMI). Currently, there are still numerous patients suffering from recurrent angina after ... ...

    Abstract Abstract Introduction Unstable angina pectoris (UAP) is the common type of coronary heart disease with the risk of developing into acute myocardial infarction (AMI). Currently, there are still numerous patients suffering from recurrent angina after revascularization or conventional medication due to the microvascular lesions, endothelial dysfunction, chronic inflammation, in-stent restenosis, and other factors. As an important part of China’s medical and health care system, traditional Chinese medicine (TCM) has rich clinical experience in the treatment of UAP. According to the theory of TCM, Yang deficiency and blood stasis syndrome is a common type of UAP. Wen Xin decoction, as a type of Chinese herbal medicine, has been used in the clinic for years and shown great efficacy in the treatment of UAP with Yang deficiency and blood stasis syndrome. This study aims to evaluate the efficacy and safety of Wen Xin granular in patients with UAP. Methods and analysis This is a double-blinded, randomized, placebo-controlled clinical trial. A total of 502 participants will be randomly allocated to the intervention group and the placebo group. Based on conventional medication, the intervention group will be treated with Wen Xin granular and the placebo group will be treated with Wen Xin granular placebo. The primary outcomes are major adverse cardiovascular events (MACE). Assessments will be performed 1 year after the treatment. The secondary outcomes include TCM symptom scale score, Seattle angina questionnaire, and thromboelastography. Assessments will be performed at baseline (before randomization) and 4 and 8 weeks after randomization. Discussion This trial will provide high-quality data on the benefits and risks of Wen Xin granular in patients with UAP. Trial registration ClinicalTrials.gov NCT04661709 . Registered on 30 November 2020
    Keywords Coronary heart disease ; Unstable angina pectoris ; Wen Xin decoction ; Chinese herb medicine ; Randomized controlled trial ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2021-11-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: YinQiSanHuang Jiedu decoction for the treatment of hepatitis B-related compensated liver cirrhosis

    Qing-Juan Wu / Wen-Liang Lv / Juan-Mei Li / Ting-Ting Zhang / Wen-Hui Zhou / Qiang Zhang / Jiu-Chong Wang / Qing-Nan Wang / Zi-Ang Yao / Rui Qiang / Si-Tong Chen / Xin Zhao / Shuang Liu / Zheng-Min Cao / Lei Xu / Gao-Hui Li / Jing Chen / Li Wang

    Trials, Vol 22, Iss 1, Pp 1-

    study protocol for a multi-center randomized controlled trial

    2021  Volume 11

    Abstract: Abstract Introduction Hepatitis B-related compensated liver cirrhosis is related to a higher risk of hepatocellular carcinoma, and antiviral therapy is the preferred method. As the pathological mechanisms of liver fibrosis are complex, drugs developed ... ...

    Abstract Abstract Introduction Hepatitis B-related compensated liver cirrhosis is related to a higher risk of hepatocellular carcinoma, and antiviral therapy is the preferred method. As the pathological mechanisms of liver fibrosis are complex, drugs developed for a single target are difficult to be effective in clinical practice, so there are no chemical drugs or biological drugs with clear efficacy available for clinical application at present. Traditional Chinese medicine is a kind of medical science that has been gradually formed during thousands of years and continuously enriched by the people of all ethnic groups in China. Traditional Chinese medicine shows curative effects in the treatment of liver diseases, especially in the field of liver fibrosis prevention and treatment. This study aims to test the integrative medicine (Chinese medicine plus antiviral therapy) effective on lowing hepatocellular carcinoma risk among patients with hepatitis-related compensated liver cirrhosis. Methods and analysis This is a multi-center randomized controlled trial, and a total of 5 hospitals and 802 patients will be involved in. All the subjects are randomly allocated to the YinQiSanHuang Jiedu decoction (YQSHD) group (n = 401) or the placebo group (n = 401). The YQSHD group receives YQSHD granule with entecavir (ETV), and the placebo group receives YQSHD placebo with ETV. The treatment period will last for 52 weeks, and the follow-up period for 52 ± 2 weeks. The primary outcome measure is the annual incidence of HCC. Outcomes will be assessed at baseline and after treatment. The objective of this trial is “the integrative of YQSHD with ETV reduce the annual incidence of HCC to 1%.” Ethics and dissemination The protocol has been approved by the Medical Ethics Committee of Guang’anmen Hospital, China (No.2019-006-KY), and the other centers in the trial will not begin recruiting until the local ethical approval has been obtained. Trial final results will be disseminated via publication. Trial registration Chinese Clinical Trial ...
    Keywords Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2021-10-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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    Inter-library loan at ZB MED

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  3. Article ; Online: Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B

    Qing-Juan Wu / Wen-Liang Lv / Juan-Mei Li / Ting-Ting Zhang / Wen-hui Zhou / Qiang Zhang / Jiu-Chong Wang / Qing-Nan Wang / Ruo-Xuan Zhang / Xin Zhao / Si-Tong Chen / Shuang Liu / Gao-Hui Li / Zheng-Min Cao / Lei Xu / Jing Chen

    Trials, Vol 21, Iss 1, Pp 1-

    study protocol for a randomized, placebo-controlled, double-blinded trial

    2020  Volume 10

    Abstract: Abstract Introduction Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies have shown that a combined therapy of traditional Chinese medicine (TCM) and conventional antiviral drugs has better ... ...

    Abstract Abstract Introduction Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies have shown that a combined therapy of traditional Chinese medicine (TCM) and conventional antiviral drugs has better efficacy than conventional antiviral for treatment of CHB. YinQiSanHuang-antiviral decoction (YQSH) is a TCM compound preparation that has shown an effect on anti-hepatitis B virus and on slowing progression of hepatitis B-related liver diseases. To evaluate the efficacy and safety of YQSH combined with entecavir and its preventive effect on hepatitis B cirrhosis, we designed this randomized, double-blind and placebo-controlled trial. The objective is that the combination of YinQiSanHuang-antiviral decoction with entecavir will reduce the annual incidence of liver fibrosis/cirrhosis to 1%. Methods This is a multicenter, randomized, placebo-controlled, double-blinded trial involving five hospitals. A total of 802 patients are randomly allocated to two groups: the YQSH group (n = 401) or the placebo group (n = 401). The YQSH group receives YQSH with entecavir; the placebo group receives granules of placebo with entecavir. Patients receive treatment for 52 weeks and then are followed up for 52 ± 2 weeks. The primary outcome measure is the annual incidence of cirrhosis. The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients’ clinical symptoms, and safety assessment. Outcomes will be assessed at baseline and after treatment. Discussion Combination therapy could become a trend for treatment of CHB, and this trial expects to provide credible clinical evidence for the future combination of TCM and conventional antiviral drugs for the treatment of CHB. Trial ...
    Keywords Chronic hepatitis B ; Cirrhosis ; Traditional Chinese medicine ; Clinical trial ; Efficacy ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2020-06-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

    More links

    Kategorien

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

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