PMID- 38169574 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240105 IS - 1178-7074 (Print) IS - 1178-7074 (Electronic) IS - 1178-7074 (Linking) VI - 16 DP - 2023 TI - 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. PG - 6177-6188 LID - 10.2147/IJGM.S436999 [doi] AB - 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). CI - (c) 2023 He et al. FAU - He, Xingling AU - He X AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - Lingnan Medical Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - University Key Laboratory of Traditional Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou, Guangdong Province, People's Republic of China. AD - Guangzhou Key Laboratory for Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. FAU - Jiang, Yanhui AU - Jiang Y AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. FAU - Li, Sijing AU - Li S AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - Lingnan Medical Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - University Key Laboratory of Traditional Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou, Guangdong Province, People's Republic of China. AD - Guangzhou Key Laboratory for Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. FAU - Liu, Donghua AU - Liu D AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - Lingnan Medical Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - University Key Laboratory of Traditional Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou, Guangdong Province, People's Republic of China. AD - Guangzhou Key Laboratory for Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. FAU - Li, Ziru AU - Li Z AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - Lingnan Medical Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - University Key Laboratory of Traditional Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou, Guangdong Province, People's Republic of China. AD - Guangzhou Key Laboratory for Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. FAU - Han, Xiaowei AU - Han X AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - Lingnan Medical Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - University Key Laboratory of Traditional Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou, Guangdong Province, People's Republic of China. AD - Guangzhou Key Laboratory for Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. FAU - Zhang, Xiaojiao AU - Zhang X AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - Lingnan Medical Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - University Key Laboratory of Traditional Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou, Guangdong Province, People's Republic of China. AD - Guangzhou Key Laboratory for Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. FAU - Dong, Xiaoming AU - Dong X AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. FAU - Liu, Haohui AU - Liu H AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. FAU - Huang, Jie AU - Huang J AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. FAU - Wang, Xiaojing AU - Wang X AD - Clinical Medical Center, Tasly Pharmaceutical Group Co. Ltd., Tianjin, People's Republic of China. FAU - Long, Wenjie AU - Long W AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. FAU - Ni, Shihao AU - Ni S AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - Lingnan Medical Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. AD - University Key Laboratory of Traditional Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou, Guangdong Province, People's Republic of China. AD - Guangzhou Key Laboratory for Chinese Medicine Prevention and Treatment of Chronic Heart Failure, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. FAU - Yang, Zhongqi AU - Yang Z AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. FAU - Ye, Taochun AU - Ye T AD - Department of Geriatrics, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. LA - eng SI - ClinicalTrials.gov/NCT04983043 PT - Journal Article DEP - 20231228 PL - New Zealand TA - Int J Gen Med JT - International journal of general medicine JID - 101515487 PMC - PMC10758342 OTO - NOTNLM OT - Chinese medicine OT - QiShen YiQi Dripping Pill OT - coronary heart disease OT - heart failure OT - syndrome of Qi deficiency with blood stasis COIS- The authors declare that they have no conflicts of interest in this work. EDAT- 2024/01/04 01:18 MHDA- 2024/01/04 01:19 PMCR- 2023/12/28 CRDT- 2024/01/03 11:42 PHST- 2023/08/24 00:00 [received] PHST- 2023/12/13 00:00 [accepted] PHST- 2024/01/04 01:19 [medline] PHST- 2024/01/04 01:18 [pubmed] PHST- 2024/01/03 11:42 [entrez] PHST- 2023/12/28 00:00 [pmc-release] AID - 436999 [pii] AID - 10.2147/IJGM.S436999 [doi] PST - epublish SO - Int J Gen Med. 2023 Dec 28;16:6177-6188. doi: 10.2147/IJGM.S436999. eCollection 2023.