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Efficacy and safety of Zhen Wu Decoction against chronic heart failure: A protocol of randomized, double-blinded, and
Jian Liang1, Xianming Tao, Dabi Hu
1The People's Hospital of Dazu, Chongqing Dazu, Chongqing, China.
Insights
This study evaluates Zhen Wu Decoction (ZWD) for chronic heart failure (CHF). It assesses ZWD
Area of Science:
- Cardiology and Traditional Chinese Medicine
Background:
- Chronic heart failure (CHF) poses a significant threat to patient survival and quality of life, with current treatments having limitations.
- Despite modern therapies, many patients experience recurrent hospitalizations, inadequate efficacy, and adverse effects.
- Zhen Wu Decoction (ZWD), a traditional Chinese medicine, is widely used for CHF in China.
Purpose of the Study:
- To evaluate the efficacy and safety of Zhen Wu Decoction (ZWD) in treating patients with chronic heart failure (CHF).
Main Methods:
- A prospective, double-blinded, randomized, controlled study design.
- Participants will be randomized (1:1) into a treatment group (guideline-directed medical therapies + ZWD) and a control group (guideline-directed medical therapies + ZWD simulation).
- Key efficacy endpoints include left ventricular ejection fraction, cardiac dimensions, NT-proBNP levels, and exercise capacity metrics.
Main Results:
- Efficacy and safety data will be collected and analyzed.
Conclusions:
- The study aims to provide evidence on the effectiveness and safety of ZWD for CHF treatment.
Introduction:
Chronic heart failure (CHF) is the end stage of several cardiac diseases. 50% of patients with severe CHF would survive less than 1 year, which has seriously affected patients' survival and quality of life. The current modern therapy could improve survival and quality of life. However, a larger number of patients still suffer from repeated hospitalization, unsatisfactory efficacy, and many side effects. In China, Zhen Wu Decoction (ZWD), a classic prescription recorded in Treatise on Febrile Diseases, was widely used for CHF. In this study, we try to conduct a prospective, double-blinded, randomized, controlled study to evaluate the efficacy and safety of ZWD in the treatment of CHF patients in China.
Methods:
Patients will be randomly divided into treatment group and control group in 1:1 ratio. Guideline directed medical therapies and ZWD will be provided for patients in treatment group, while guideline directed medical therapies and ZWD-granules simulations for control group. Left ventricular ejection fraction, left ventricular end diastolic diameter, left ventricular end systolic diameter, b-type natriuretic peptide, NT-proBNP, peak VO2, VO2 maximum, exercise time, and walking distance will be recorded. The data will be analyzed by SPSS 22.0.
Conclusions:
The results will evaluate the efficacy and safety of ZWD in the treatment of CHF patients.
Trial Registration:
OSF registration number: DOI 10.17605/OSF.IO/G3QNU.
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