Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre
1 other identifier
interventional
636
1 country
60
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 heart-failure
Started Jun 2026
Shorter than P25 for phase_3 heart-failure
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 22, 2026
CompletedFirst Submitted
Initial submission to the registry
June 24, 2026
CompletedFirst Posted
Study publicly available on registry
July 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 22, 2028
July 7, 2026
June 1, 2026
2 years
June 24, 2026
July 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in 6-minute Walk Distance (6MWD) at Week 12 (Larger Distances Represent Better Exercise Functional Capacity).
At baseline and at week 12.
Secondary Outcomes (16)
Change From Baseline in 6-minute Walk Distance (6MWD) at Week 4 and Week 8.
At baseline and at week 4 and week 8.
Change From Baseline in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score at Week 4, Week 8 and Week 12. (Higher Scores Represent Lower Quality of Life).
At baseline and at week 4, week 8 and week 12.
The Disappearance Rate of Heart Failure Symptoms (shortness of breath, fatigue, edema) at Week 4, Week 8 and Week 12.
At baseline and at week 4, week 8 and week 12.
Change From Baseline in Traditional Chinese Medicine (TCM) Syndrome Score at Week 4, Week 8 and Week 12. (Higher Scores Represent Sever TCM Syndrome).
At baseline and at week 4, week 8 and week 12.
The Total Effective Rate in Traditional Chinese Medicine (TCM) Syndrome at Week 4, Week 8 and Week 12.
At baseline and at week 4, week 8 and week 12.
- +11 more secondary outcomes
Study Arms (2)
Qishen Yiqi Dripping Pills, 2 bags, take orally half an hour after meals, 3 times a day
EXPERIMENTALQishen Yiqi Dripping Pills placebo, 2 bags, take orally half an hour after meals, 3 times a day
PLACEBO COMPARATORInterventions
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Bozhou People's Hospital
Bozhou, Anhui, China
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
Anhui Suzhou Municipal Hospital
Suzhou, Anhui, China
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Gansu Provincial Hospital
Lanzhou, Gansu, China
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China
Qingyang People's Hospital
Qingyang, Gansu, China
Guangzhou University of Chinese Medicine Dongguan Hospital (Dongguan Hospital of Traditional Chinese Medicine)
Dongguan, Guangdong, China
Guangzhou Red Cross Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Liuzhou People's Hospital
Liuzhou, Guangxi, China
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, China
The First People's Hospital of Yulin
Yulin, Guangxi, China
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Affiliated Hospital of North China University of Science and Technology
Tangshan, Hebei, China
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei, China
Xingtai Central Hospital
Xingtai, Hebei, China
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, China
Daqing People's Hospital
Daqing, Heilongjiang, China
Heilongjiang Provincial Hospital
Harbin, Heilongjiang, China
Hebi People's Hospital
Hebi, Henan, China
Huaihe Hospital of Henan University
Kaifeng, Henan, China
The First Affiliated Hospital of Henan University
Kaifeng, Henan, China
Luoyang Third People's Hospital
Luoyang, Henan, China
Puyang Oilfield General Hospital
Puyang, Henan, China
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Xinxiang Central Hospital
Xinxiang, Henan, China
Huangshi Central Hospital
Huangshi, Hubei, China
Shiyan People's Hospital
Shiyan, Hubei, China
Wuhan Third Hospital
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Jinzhou Central Hospital
Jinzhou, Liaoning, China
Panjin Central Hospital
Panjin, Liaoning, China
Liaoning Provincial People's Hospital
Shenyang, Liaoning, China
Chifeng Municipal Hospital
Chifeng, Neimenggu, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Xi'an Daxing Hospital
Xi'an, Shaanxi, China
Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
Heze Municipal Hospital
Heze, Shandong, China
Shandong Second Provincial People's Hospital
Jinan, Shandong, China
Jining First People's Hospital
Jining, Shandong, China
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Mianyang Traditional Chinese Medicine Hospital
Mianyang, Sichuan, China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Tianjin Fourth Central Hospital
Tianjin, Tianjin Municipality, China
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, China
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
Lishui Central Hospital
Lishui, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2026
First Posted
July 7, 2026
Study Start
June 22, 2026
Primary Completion (Estimated)
June 22, 2028
Study Completion (Estimated)
June 22, 2028
Last Updated
July 7, 2026
Record last verified: 2026-06