Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Qi Deficiency with Blood Stasis): Study Protocol for a Randomized, Placebo-Controlled, Double-Blind and Multi-Centre Phase II Clinical Trial

Xingling He; Yanhui Jiang; Sijing Li; Donghua Liu; Ziru Li; Xiaowei Han; Xiaojiao Zhang; Xiaoming Dong; Haohui Liu; Jie Huang; Xiaojing Wang; Wenjie Long; Shihao Ni; Zhongqi Yang; Taochun Ye

doi:10.2147/IJGM.S436999

Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Qi Deficiency with Blood Stasis): Study Protocol for a Randomized, Placebo-Controlled, Double-Blind and Multi-Centre Phase II Clinical Trial

Int J Gen Med. 2023 Dec 28:16:6177-6188. doi: 10.2147/IJGM.S436999. eCollection 2023.

Authors

Xingling He^#^{1

2

3

4}, Yanhui Jiang^#¹, Sijing Li^#^{1

2

3

4}, Donghua Liu^{1

2

3

4}, Ziru Li^{1

2

3

4}, Xiaowei Han^{1

2

3

4}, Xiaojiao Zhang^{1

2

3

4}, Xiaoming Dong¹, Haohui Liu¹, Jie Huang¹, Xiaojing Wang⁵, Wenjie Long¹, Shihao Ni^{1

2

3

4}, Zhongqi Yang¹, Taochun Ye¹

Affiliations

¹ Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.
² Lingnan Medical Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.
³ University Key Laboratory of Traditional Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou, Guangdong Province, People's Republic of China.
⁴ Guangzhou Key Laboratory for Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.
⁵ Clinical Medical Center, Tasly Pharmaceutical Group Co. Ltd., Tianjin, People's Republic of China.

^# Contributed equally.

Abstract

Background: Heart failure (HF) is a serious and terminal stage of various cardiac diseases and the most common complication of coronary heart disease (CHD). Previous clinical studies have shown that Qishen Yiqi dropping pills (QSYQ) have the effect of treating chronic heart failure. This study aims to evaluate the clinical efficacy, safety and optimal effective dose of QSYQ in treating CHD complicating chronic HF with reduced ejection fraction (HFrEF).

Methods: We will conduct a randomized, double-blind, placebo controlled, multicenter clinical trial. A total of 228 individuals from 16 hospitals in China will be randomly assigned to the low-dose, high-dose, and placebo groups in a ratio of 1:1:1. The trial consists of a screening period (standard medical treatment for at least 2 weeks) and a 12-week treatment period. After randomization, follow-up will be conducted at the 4th, 8th and 12th week. The primary outcomes will be the 6-Minute Walk Test (6MWT) at Week 12. Secondary outcomes will include 6MWT distance at Week 4 and 8, New York Heart Association (NYHA) functional classification, Traditional Chinese Medicine (TCM) Syndrome score, echocardiography indices, N-terminal pro-B-type natriuretic peptide (NT-proBNP), oxyhemoglobin saturation, Minnesota living with heart failure questionnaire (MLHFQ) score, grasp strength body mass index test and cardiovascular adverse events (AE).

Ethics and dissemination: This trial has been approved by the Research Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine, China (approval number: ZYYEC [2021]005). Written informed consent will be obtained from all participants. The results of this trial will be publicly shared through academic conferences and peer-reviewed journals.

Study registration: Clinical Trials Registry (NCT04983043, Date: 07/08/2021, https://clinicaltrials.gov/ct2/show/NCT04983043).

Keywords: Chinese medicine; QiShen YiQi Dripping Pill; coronary heart disease; heart failure; syndrome of Qi deficiency with blood stasis.

Associated data

ClinicalTrials.gov/NCT04983043

Grants and funding

This study is supported by the National Natural Science Foundation of China (Grant number: 82205236), Research Project of Traditional Chinese medicine Bureau of Guangdong Province (No. 2022ZYYJ01), Joint Funding Program between the City and the University/Institute (College) (No. 202201020474) and Guangzhou Science and Technology Plan Project (No. 202102080228). The funding sources have no role in the design of this study and will play no role in its execution, analyses, data interpretation, or decision to submit results.