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.

"Disclosure The authors declare that they have no conflicts of interest in this work."

"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."

"Ethics approval was obtained from the Clinical Research Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine (No. ZYYEC-2021-005) on 30 March 2021. The study has been registered in ClinicalTrials.gov with the ID NCT04983043 and updated on November 17, 2022 (Version 2.0). All items were drawn from the World Health Organization Trial Registration Dataset. The trial’s test medication, QiShen YiQi Dripping Pills, is a commercially available drug with the National Medical Products Administration approval (Approval Nos.: GYZZ Z20030139; GYZZ Z20113048). Tasly Pharmaceutical Group Co., LTD., the trial’s manufacturer, has been informed of the trial and has provided the test drug and placebo for this trial. Prior to enrollment, each participant will sign an informed consent form, and they will only be treated by a licensed clinician throughout the study. The study will adhere to the Helsinki Declaration, participants can decide to leave the trial at any moment, and any information that might reveal personal information will be kept secret. Study Registration: Clinical Trials Registry (NCT04983043, Date: 07/08/2021, https://clinicaltrials.gov/ct2/show/NCT04983043). Trial Status: This study was registered with the Chinese Clinical Trial Register (NCT04983043) on July 8, 2021. The recruitment of participants has started in July 2021 and is going."