title: Chinese Herbal Medicine in the Treatment of Chronic Heart Failure: Three-Stage Study Protocol for a Randomized Controlled Trial.
abstract: Background. Chinese herbal medicine (CHM) has been used in the treatment of chronic heart failure (CHF) for a long time. Treatment based on syndrome differentiation and the main characteristic of TCM is the fundamental principle of TCM practice. In this study protocol, we have designed a trial to assess the efficacy and safety of CHM on CHF based on syndrome differentiation. Methods/Design. This is a three-stage trial of CHM in the treatment of CHF. The first stage is a literature review aiming to explore the common syndromes of CHF. The second is a multicentral, randomized, placebo-controlled trial to evaluate the efficacy and safety of CHM for the treatment of CHF. The third is a multicentral, randomized controlled clinical trial aiming to make cost-effectiveness analysis and evaluate the feasibility, compliance, and universality of CHM on CHF. Discussion. This trial will evaluate the efficacy, safety, feasibility, compliance, and universality of CHM on CHF. The expected outcome is to provide evidence-based recommendations for CHM on CHF and develop a prescription of CHM in the treatment of CHF. This trial is registered with NCT01939236 (Stage Two of the whole trial).
authors.affiliation: School of Preclinical Medicine, Beijing University of Chinese Medicine, No. 11, Beisanhuan Donglu, Chaoyang District, Beijing 100029, China ; School of Traditional Chinese Medicine, Capital Medical University, No. 10, Youanmenwai, Xitoutiao, Fengtai District, Beijing 100069, China.
authors.forename: Liangtao
authors.initials: L
authors.lastname: Luo
authors.affiliation: School of Preclinical Medicine, Beijing University of Chinese Medicine, No. 11, Beisanhuan Donglu, Chaoyang District, Beijing 100029, China.
authors.forename: Jianxin
authors.initials: J
authors.lastname: Chen
authors.affiliation: School of Preclinical Medicine, Beijing University of Chinese Medicine, No. 11, Beisanhuan Donglu, Chaoyang District, Beijing 100029, China.
authors.forename: Shuzhen
authors.initials: S
authors.lastname: Guo
authors.affiliation: School of Preclinical Medicine, Beijing University of Chinese Medicine, No. 11, Beisanhuan Donglu, Chaoyang District, Beijing 100029, China.
authors.forename: Juan
authors.initials: J
authors.lastname: Wang
authors.affiliation: School of Preclinical Medicine, Beijing University of Chinese Medicine, No. 11, Beisanhuan Donglu, Chaoyang District, Beijing 100029, China.
authors.forename: Kuo
authors.initials: K
authors.lastname: Gao
authors.affiliation: School of Preclinical Medicine, Beijing University of Chinese Medicine, No. 11, Beisanhuan Donglu, Chaoyang District, Beijing 100029, China ; Wuhan Hospital of Traditional Chinese Medicine, No. 49, Li Huang Po Lu, Han Kou Jiang An District, Wuhan, Hubei 430014, China.
authors.forename: Peng
authors.initials: P
authors.lastname: Zhang
authors.affiliation: School of Preclinical Medicine, Beijing University of Chinese Medicine, No. 11, Beisanhuan Donglu, Chaoyang District, Beijing 100029, China ; Hangzhou Xiaoshan District Hospital of Traditional Chinese Medicine, 156 Yu Cai Lu, Xiaoshan District, Zhejiang 311201, China.
authors.forename: Chan
authors.initials: C
authors.lastname: Chen
authors.affiliation: School of Preclinical Medicine, Beijing University of Chinese Medicine, No. 11, Beisanhuan Donglu, Chaoyang District, Beijing 100029, China.
authors.forename: Huihui
authors.initials: H
authors.lastname: Zhao
authors.affiliation: School of Preclinical Medicine, Beijing University of Chinese Medicine, No. 11, Beisanhuan Donglu, Chaoyang District, Beijing 100029, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang