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Clinical Trials in China / NCT07687186
Recruiting Phase 3

Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre

NCT07687186 · tracked via the Priya Life Science China tracker
Sponsor
Tasly Pharmaceutical Group Co., Ltd
Phase
Phase 3
Started
2026-06-22
Last updated
2026-07-07

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Qishen Yiqi Dripping Pills 2 bagsQishen Yiqi Dripping Pills placebo 2 bags

Qishen Yiqi Dripping Pills 2 bags: Qishen Yiqi Dripping Pills contain Qishen Yiqi Dripping Pills 2 bags(0.52g dripping pills per bag), take orally half an hour after meals, 3 times a day for 12 weeks

Qishen Yiqi Dripping Pills placebo 2 bags: Qishen Yiqi Dripping Pills placebo contain Qishen Yiqi Dripping Pills placebo 2 bags(0.52g dripping pills placebo per bag), take orally half an hour after meals, 3 times a day for 12 weeks

Study summary

This trial will evaluate the efficacy and safety of Qishen Yiqi Dripping Pills in treatment of Chronic Heart Failure with reduced ejection fraction resorted from Coronary Heart Disease (Syndrome of Qi Deficiency with Blood Stasis).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Male or female subjects aged ≥ 18 years and ≤80 years when signing the informed consent form. * Conformed to the diagnostic criteria of coronary heart disease and chronic heart failure. * Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis. * NYHA Functional Classification Ⅱ-Ⅲ. * Left ventricular ejection fraction (LVEF) \< 45% (modified two-plane Simpson method). * Received standardized drug therapy for chronic heart failure at least 2 weeks before randomization without adjustment of dose, and did not receive intravenous therapy (vasoactive drugs, diuretics) within 2 weeks. * Voluntarily participate in the clinical trial, sign the informed consent form, and be able to understand and comply with the trial procedures. Exclusion Criteria: * Heart failure caused by other cardiovascular diseases, such as infectious endocarditis, cardiac amyloidosis, genetic abnormalities (genetic factors related to hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy), valve and cardiac structure abnormalities (moderate or above aortic valve stenosis, other severely narrowed or incompetent heart valves, congenital heart disease), constrictive pericarditis, moderate or large pericardial effusion. * Heart failure caused by other non-cardiovascular diseases, such as severe infection, autoimmune diseases, tumor metastasis or infiltration, pulmonary heart disease, primary pulmonary hypertension, secondary severe pulmonary hypertension, kidney diseases, liver diseases, cardiac toxic injury (cardiotoxic drugs such as anti-tumor drugs, alcoholic cardiomyopathy). * Within 3 months before receiving the investigational drug, had acute myocardial infarction, undergone revascularization \[percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG)\] treatment, undergone left ventricular assist device \[cardiac resynchronization therapy (CRT), implantable cardioverter defibrillator (ICD), etc.\] treatment, undergone cardiac surgery (left ventricular reconstruction, heart transplantation, etc.) treatment, had acute cerebrovascular events (acute ischemic stroke, cerebral hemorrhage, transient ischemic attack). * Planned to undergo revascularization (PCI, CABG, etc.) or left ventricular assist device (CRT, ICD, etc.) treatment, or other cardiac surgery during the trial. * Had severe, progressive, or uncontrolled diseases, including but not limited to immune system, endocrine system, blood system, urinary system, liver and gallbladder system, respiratory system, nervous system, mental system, cardiovascular system, gastrointestinal system or infectious diseases, malignant tumors, etc. * Had uncontrolled hypertension (after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), or had hypotension (systolic blood pressure \< 80 mmHg and/or diastolic blood pressure \< 50 mmHg). * Severe arrhythmias such as ventricular tachycardia, second-degree type II or above sinus or atrioventricular conduction block without pacemaker treatment. * Abnormal liver function tests \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the upper limit of the normal value of the laboratory in this center\], or abnormal renal function tests \[serum creatinine (Cr) \> 1.5 times the upper limit of the normal value of the laboratory\]. * Glycated hemoglobin (HbA1c) ≥ 9.0%. * Hemoglobin (Hb) \< 90 g/L. * Serum potassium concentration \> 5.5 mmol/L. * Need to take anticoagulants, dose stable for less than 1 month, or INR \> 3.0. * Need to take antiplatelet drugs, dose stable for less than 1 month, and platelets lower than the lower limit of the normal value. * Allergic to the Chinese medicine formula of Qishen YiQi (QSYQ) Dripping Pills (Astragalus membranaceus, Salvia miltiorrhiza, Panax notoginseng, and Dalbergia odorifera), or allergic to other Chinese medicines with the same ingredients or the same therapeutic functions. * Within 2 weeks before randomization, had received drugs affecting exercise tolerance assessment (such as trimetazidine, renozine, coenzyme Q10, levocarnitine, and androgens) or Chinese medicine preparations with the same ingredients or the same therapeutic functions. * Had absolute contraindications for the 6-minute walk test or was unable to complete the 6-minute walk test. * Had participated in other interventional drug clinical trials within 1 month before screening. * Pregnant or lactating women, or had a pregnancy plan or could not take effective contraceptive measures from the screening period to the end of the trial and within 1 month after the last administration. * Any other circumstances where other researchers deem it inappropriate for a participant to take part in the trial, such as if the participant has potential issues with compliance, is unable to complete all the examinations and evaluations as per the protocol requirements, or if there are uncontrollable risks associated with participating in the trial.

Primary outcome measure(s)

Trial sites (60)

FacilityCityRegionStatus
Bozhou People's Hospital Bozhou Anhui Not Yet Recruiting
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) Hefei Anhui Not Yet Recruiting
Anhui Suzhou Municipal Hospital Suzhou Anhui Not Yet Recruiting
Xiyuan Hospital, China Academy of Chinese Medical Sciences Beijing Beijing Municipality Not Yet Recruiting
Fujian Provincial Hospital Fuzhou Fujian Not Yet Recruiting
Gansu Provincial Hospital Lanzhou Gansu Not Yet Recruiting
The Second Hospital of Lanzhou University Lanzhou Gansu Not Yet Recruiting
Qingyang People's Hospital Qingyang Gansu Not Yet Recruiting
Guangzhou University of Chinese Medicine Dongguan Hospital (Dongguan Hospital of Traditional Chinese Medicine) Dongguan Guangdong Not Yet Recruiting
Guangzhou Red Cross Hospital Guangzhou Guangdong Not Yet Recruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou Guangdong Recruiting
Liuzhou People's Hospital Liuzhou Guangxi Not Yet Recruiting
The First Affiliated Hospital of Guangxi University of Chinese Medicine Nanning Guangxi Not Yet Recruiting
The First People's Hospital of Yulin Yulin Guangxi Not Yet Recruiting
Hebei Provincial Hospital of Traditional Chinese Medicine Shijiazhuang Hebei Not Yet Recruiting
The First Hospital of Hebei Medical University Shijiazhuang Hebei Not Yet Recruiting
Affiliated Hospital of North China University of Science and Technology Tangshan Hebei Not Yet Recruiting
The Second Affiliated Hospital of Xingtai Medical College Xingtai Hebei Not Yet Recruiting
Xingtai Central Hospital Xingtai Hebei Not Yet Recruiting
The First Affiliated Hospital of Hebei North University Zhangjiakou Hebei Not Yet Recruiting
Daqing People's Hospital Daqing Heilongjiang Not Yet Recruiting
Heilongjiang Provincial Hospital Harbin Heilongjiang Not Yet Recruiting
Hebi People's Hospital Hebi Henan Not Yet Recruiting
Huaihe Hospital of Henan University Kaifeng Henan Not Yet Recruiting
The First Affiliated Hospital of Henan University Kaifeng Henan Not Yet Recruiting
Luoyang Third People's Hospital Luoyang Henan Not Yet Recruiting
Puyang Oilfield General Hospital Puyang Henan Not Yet Recruiting
The Third Affiliated Hospital of Xinxiang Medical University Xinxiang Henan Not Yet Recruiting
Xinxiang Central Hospital Xinxiang Henan Not Yet Recruiting
Huangshi Central Hospital Huangshi Hubei Not Yet Recruiting
Shiyan People's Hospital Shiyan Hubei Not Yet Recruiting
Wuhan Third Hospital Wuhan Hubei Not Yet Recruiting
Yichang Central People's Hospital Yichang Hubei Not Yet Recruiting
The First Affiliated Hospital of Hunan University of Chinese Medicine Changsha Hunan Not Yet Recruiting
Xiangya Hospital, Central South University Changsha Hunan Not Yet Recruiting
The First Affiliated Hospital of University of South China Hengyang Hunan Not Yet Recruiting
Affiliated Hospital of Nanjing University of Chinese Medicine Nanjing Jiangsu Not Yet Recruiting
Pingxiang People's Hospital Pingxiang Jiangxi Not Yet Recruiting
Jinzhou Central Hospital Jinzhou Liaoning Not Yet Recruiting
Panjin Central Hospital Panjin Liaoning Not Yet Recruiting

+ 20 more sites — see the full list on the official registry below.

More Tasly Pharmaceutical Group Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07687186 on ClinicalTrials.gov ↗ ← All trials in China