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Efficacy of Xinbao pill on chronic heart failure: Study protocol of a multicenter, randomized, double-blind, placebo-controlled trial.

ABSTRACT: Introduction: Chronic heart failure (CHF) is a common cardiovascular disease. In China, Xinbao pill (XBP) is widely used as an adjuvant therapy for CHF. However, there is still a lack of high-quality clinical evidence. We designed this multicenter, randomized, double-blind, placebo-controlled trial to critically evaluate the efficacy and safety of XBP as an adjuvant treatment for patients with CHF. Methods and analysis: We will recruit 284 patients with a clinical diagnosis of "heart-kidney yang deficiency syndrome" CHF receiving treatment in six hospitals in China. Patients will be randomly assigned, in a 1:1 ratio, to the treatment or control group using a central randomization system. All patients will receive conventional drug therapy for heart failure combined XBP (Guangdong Xinbao Pharmaceutical Co., Ltd., Guangdong, China) or a placebo. Study physicians, subjects, outcome assessors, and statisticians will be blinded to the group assignment. The primary outcome will be the change in the proportion of patients who show a decrease in serum NT-proBNP of more than 30% after treatment. Secondary outcomes are NYHA class, 6-minute walk distance test, Minnesota Quality of Life Scale score, endpoint events, serum NT-proBNP, echocardiographic parameters, and traditional Chinese medicine (TCM) symptom score. Adverse events will be monitored throughout the trial. Data will be analyzed according to a predetermined statistical analysis plan. Discussion: The results of this study will provide solid evidence of the safety and efficacy of XBP as an alternative and complementary treatment measure for patients with CHF. Clinical Trial Registration: Chinese Clinical Trial Registration Center (ChiCTR2000038492).

SUBMITTER: Wang Y

PROVIDER: S-EPMC9640989 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Efficacy of Xinbao pill on chronic heart failure: Study protocol of a multicenter, randomized, double-blind, placebo-controlled trial.

Wang Yuanping Y Li Jiahua J Yan Jiaqi J Wang Yulin Y Cheng Yuanyuan Y Liu Zhongqiu Z Wang Dawei D

Frontiers in pharmacology 20221025

<b>Introduction:</b> Chronic heart failure (CHF) is a common cardiovascular disease. In China, Xinbao pill (XBP) is widely used as an adjuvant therapy for CHF. However, there is still a lack of high-quality clinical evidence. We designed this multicenter, randomized, double-blind, placebo-controlled trial to critically evaluate the efficacy and safety of XBP as an adjuvant treatment for patients with CHF. <b>Methods and analysis:</b> We will recruit 284 patients with a clinical diagnosis of "hea ...[more]

PMID: 36386125

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Project description:BackgroundApproximately 15% of couples in the reproductive age are affected by infertility. Women with diminished ovarian reserves (DOR) or with a poor ovarian response (POR) are required to undergo in vitro fertilization and embryo transfer (IVF-ET) to achieve pregnancy. However, studies indicate that poor response to gonadotropin stimulation has been reported in women undergoing IVF-ET. Results from two recent clinical studies in China suggest that traditional Chinese medicine (TCM) formula Dingkun pill (DKP) showed a curative effect by improving the clinical pregnancy rate in women with DOR and POR. However, the heterogeneity of the studies does not allow one to draw a definitive conclusion on the therapeutic effect of DKP. Therefore, the purpose of this study was to investigate the effect of DKP on improving the clinical outcome of pregnancy of IVF-ET in women with low prognosis.MethodsA multicenter, double-blinded, randomized placebo-controlled trial was conducted. A total of 460 infertile patients undergoing IVF or intracytoplasmic sperm injection (ICSI) were recruited from 12 public hospitals in China. Participants were randomly divided into the experimental group (DKP formula) or the placebo group (control) at a ratio of 1:1. All patients were treated with GnRH antagonist protocol and ovarian stimulation performed for 5 weeks (from the 5th day of the previous menstrual cycle to the day of oocyte retrieval). The patients were followed up for 6 months to record their conception outcome. The primary outcome is to compare the pregnancy outcome to those under placebo treatment. Secondary outcomes included the total count of the retrieved oocyte, embryo quality, endometrial thickness on ET day, implantation rate, and early miscarriage rate.DiscussionCurrently, no multicenter, double-blind, randomized, placebo-controlled trials have been performed on the use of the DKP formula to improve on the clinical outcome of the conception of IVF-ET in women with low prognosis. DKP might provide a good clinical solution for females with low prognosis and undergoing IVF. There is no contemporary Western medicine to improve on the clinical outcome of conception in IVF-ET in women with low prognosis. Therefore, it is important to undertake a well-designed randomized trial to determine the effect of DKP in improving the clinical outcome of the conception of IVF-ET in women with low prognosis.Trial registrationChinese Clinical Trial Registry (ChiCTR).Trial registration numberChiCTR1900026614. Registered on 16 October 2019.

Project description:BACKGROUND:Heart failure (HF) is associated with decreased quality of life, high re-admission rate and poor prognosis. In particular, ischemic heart failure (IHF) has a worse prognosis than nonischemic HF. The use of traditional Chinese medicine (TCM) alongside Western medicine to treat HF has developed into an integrative treatment model in China. There have been small clinical trials and experimental studies to demonstrate the efficacy of TCM for treating HF; however, there is still a lack of high-quality trials. Qishen Yiqi dripping pills (QSYQ), a TCM drug, have been commonly used alongside standardized Western medicine to treat IHF. This paper describes the protocol for the clinical assessment of QSYQ in IHF patients. METHOD:A randomized, double-blind, multicenter, placebo-controlled trial will assess the efficacy and safety of QSYQ in the treatment of IHF. The trial is to enroll 640 IHF patients from 32 hospitals in China. Besides their standardized Western medicine, patients will be randomized to receive treatment of either QSYQ or placebo for 6 months and follow-up monitoring for at least a further 6 months. The primary outcome is increased exercise capacity of patients, which will be measured using the 6-minute walking test (6MWT). The secondary outcomes include composite endpoints: all-cause mortality, frequency of hospitalization or emergency due to cardiovascular events, brain natriuretic peptide levels, left ventricular ejection fraction, and cardiothoracic ratio will be documented, as well as scores on the New York Heart Association classification and Minnesota quality of life index, and information obtained from the four TCM diagnostic methods. Blood lipid tests will also be administered. DISCUSSION:The integrative treatment model of TCM alongside Western medicine has developed into a treatment model in China. The rigorous design of the trial will assure an objective and scientific assessment of the efficacy and safety of QSYQ in the treatment of IHF.

Dataset Information

Efficacy of Xinbao pill on chronic heart failure: Study protocol of a multicenter, randomized, double-blind, placebo-controlled trial.

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Efficacy of Xinbao pill on chronic heart failure: Study protocol of a multicenter, randomized, double-blind, placebo-controlled trial.

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