Safety and efficacy of Qishen granules in patients with chronic heart failure: study protocol for a randomized controlled trial

Jinping Wang, Jun Shi, Jiawei Wei, Juan Wang, Kuo Gao, Xueli Li, Jianxin Chen, Shaojing Li, Huihui Zhao, Wei Wang, Jinping Wang, Jun Shi, Jiawei Wei, Juan Wang, Kuo Gao, Xueli Li, Jianxin Chen, Shaojing Li, Huihui Zhao, Wei Wang

Abstract

Background: Chronic heart failure (CHF), the final stage of various cardiovascular diseases, is a major public health problem resulting in significant hospitalization rates, mortality, and huge health care costs despite advances in the treatment and management of heart failure and heart failure-related risk factors. Qishen granules (QSG), a Chinese herbal formula, is widely used by traditional Chinese medicine (TCM) practitioners to treat CHF. Several animal experimental studies have showed that QSG can significantly relieve the heart failure symptoms in CHF rat models. However, there is as yet no standard clinical trial to confirm this. Thus, the investigators are conducting this study to evaluate the efficacy and safety of QSG in a large, and varied population.

Methods/design: This study is designed as a randomized, placebo-controlled, multi-center, double-blind clinical trial with parallel groups. A total of 200 patients with CHF will be recruited and randomly allocated to either the QSG treatment group or the placebo group (in a 1:1 ratio). The patients will receive QSG or placebo granules twice a day for 12 weeks. The primary outcome is the proportion of patients in the QSG group, compared with the placebo group, demonstrating a more than 30% decrease in NT-proBNP level during 12 weeks of treatment. The secondary outcomes consist of composite cardiac events, New York Heart Association functional classification, 6-minute walking distance, left ventricular ejection fraction, patient quality of life, and the TCM syndrome integral scale.

Discussion: On a background of standard treatment, QSG may further reduce the levels of NT-proBNP. This trial will provide high-quality evidence on the efficacy and safety of QSG in treating CHF, thus providing reference for clinical application of QSG.

Trial registration: Clinical Trials.gov: NCT03027375 . Registered on 16 January 2017.

Keywords: Chronic heart failure; Efficacy; Qishen granules; Safety; Traditional Chinese herbal medicine.

Conflict of interest statement

Ethics approval and consent to participate

This study in all the three centers has been authorized by the Institutional Review Board of Beijing University of Chinese Medicine (approval number: 2017 BZHYL0101), which is the Centralized Ethics Committee of this study. We ensure that this study is conducted in accordance with the principles of the Declaration of Helsinki and the principles of Good Clinical Practice.

This trial was registered at the Clinicaltrial.gov website under the identification number NCT03027375 on 16 January 2017.

Signed informed consent forms will be obtained from all qualified participants before enrollment.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart of this study
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) flowchart

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