Heart FailurePhase 3NCT07687186
Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre
A Phase 3 study testing Qishen Yiqi Dripping Pills 2 bags in people with Heart Failure, run by Tasly Pharmaceutical Group Co., Ltd at 60 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Qishen Yiqi Dripping Pills 2 bags
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 636 participants
- Where
- 60 sitesChina
- Study dates
- 21 Aug 2026to 22 Jun 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 19Show fewer
- 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.
Trial locations and contacts
60 sites in 1 country. Contact the study team or a site near you to ask about taking part.
60 sites in 1 country
China60 sites, 60 recruiting
- Not yet recruiting
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality
Guoju Dong
- Not yet recruiting
Bozhou People's Hospital
Bozhou, Anhui
Rongyan Jiang
- Not yet recruiting
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan
Wen Zhang
- Not yet recruiting
Xiangya Hospital, Central South University
Changsha, Hunan
Yongping Bai
- Not yet recruiting
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan
Wen Xie
- Not yet recruiting
Chifeng Municipal Hospital
Chifeng, Neimenggu
Weifang Wang
- Not yet recruiting
Daqing People's Hospital
Daqing, Heilongjiang
Xianyou Ji
- Not yet recruiting
Guangzhou University of Chinese Medicine Dongguan Hospital (Dongguan Hospital of Traditional Chinese Medicine)
Dongguan, Guangdong
Xiaohan Ye
- Not yet recruiting
Fujian Provincial Hospital
Fuzhou, Fujian
Hui Chen
- Not yet recruiting
Guangzhou Red Cross Hospital
Guangzhou, Guangdong
Li Li
- Recruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong
Zhongqi Yang
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang
Liping Dou
- Not yet recruiting
Heilongjiang Provincial Hospital
Harbin, Heilongjiang
Guimin Wang
- Not yet recruiting
Hebi People's Hospital
Hebi, Henan
Xueliang Gao
- Not yet recruiting
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui
Kangyu Chen
- Not yet recruiting
The First Affiliated Hospital of University of South China
Hengyang, Hunan
Jie Wu
- Not yet recruiting
Heze Municipal Hospital
Heze, Shandong
Jihua Liang
- Not yet recruiting
Huangshi Central Hospital
Huangshi, Hubei
Daoqun Jin
- Not yet recruiting
Shandong Second Provincial People's Hospital
Jinan, Shandong
Jianqin Feng
- Not yet recruiting
Jining First People's Hospital
Jining, Shandong
Changjie Ren
- Not yet recruiting
Jinzhou Central Hospital
Jinzhou, Liaoning
Shuai Jiang
- Not yet recruiting
Huaihe Hospital of Henan University
Kaifeng, Henan
Yanming Li
- Not yet recruiting
The First Affiliated Hospital of Henan University
Kaifeng, Henan
Guihong Gong
- Not yet recruiting
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan
Lin Sun
- Not yet recruiting
Gansu Provincial Hospital
Lanzhou, Gansu
Yan Zhu
- Not yet recruiting
The Second Hospital of Lanzhou University
Lanzhou, Gansu
Shougang Sun
- Not yet recruiting
Lishui Central Hospital
Lishui, Zhejiang
Lingchun Lyu
- Not yet recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi
Yanli Liu
- Not yet recruiting
Luoyang Third People's Hospital
Luoyang, Henan
Lipeng Li
- Not yet recruiting
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan
Gang Luo
- Not yet recruiting
Mianyang Traditional Chinese Medicine Hospital
Mianyang, Sichuan
Zhonggui Liu
- Not yet recruiting
Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu
Chong Zou
- Not yet recruiting
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi
Xinbing He
- Not yet recruiting
Panjin Central Hospital
Panjin, Liaoning
Li Li
- Not yet recruiting
Pingxiang People's Hospital
Pingxiang, Jiangxi
Yuhong Zhang
- Not yet recruiting
Puyang Oilfield General Hospital
Puyang, Henan
Dianbo Wang
- Not yet recruiting
Qingyang People's Hospital
Qingyang, Gansu
Wenxia Jia
- Not yet recruiting
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
Xiaolong Wang
- Not yet recruiting
Liaoning Provincial People's Hospital
Shenyang, Liaoning
Aijie Hou
- Not yet recruiting
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei
Yali Feng
- Not yet recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Chao Liu
- Not yet recruiting
Shiyan People's Hospital
Shiyan, Hubei
Jianing Wang
- Not yet recruiting
Anhui Suzhou Municipal Hospital
Suzhou, Anhui
Hailong Qiu
- Not yet recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Jia Guo
- Not yet recruiting
Affiliated Hospital of North China University of Science and Technology
Tangshan, Hebei
Zhijun Wang
- Not yet recruiting
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality
Xuezheng Liu
- Not yet recruiting
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality
Qiang Xu
- Not yet recruiting
Tianjin Fourth Central Hospital
Tianjin, Tianjin Municipality
Yong Liu
- Not yet recruiting
Wuhan Third Hospital
Wuhan, Hubei
Dongsheng Li
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Dengfeng Gao
- Not yet recruiting
Xi'an Daxing Hospital
Xi'an, Shaanxi
Zhili Li
- Not yet recruiting
Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi
Feng Ji
- Not yet recruiting
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei
Zhongliang Wang
- Not yet recruiting
Xingtai Central Hospital
Xingtai, Hebei
Song Zhou
- Not yet recruiting
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan
Guotian Yin
- Not yet recruiting
Xinxiang Central Hospital
Xinxiang, Henan
Shuhong Su
- Not yet recruiting
Yichang Central People's Hospital
Yichang, Hubei
Lin Teng
- Not yet recruiting
The First People's Hospital of Yulin
Yulin, Guangxi
Zhengdong Wang
- Not yet recruiting
Yuncheng Central Hospital
Yuncheng, Shanxi
Yanling Qu
- Not yet recruiting
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei
Fangjiang Li
About this study
Official title: 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): A Phase 3 Randomized ControLled TrIal on Efficacy and SaFetY (QUALIFY)
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).
- Conditions
- Heart Failure
- Being tested
- Qishen Yiqi Dripping Pills 2 bags, Qishen Yiqi Dripping Pills placebo 2 bags
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qishen Yiqi Dripping Pills 2 bagsDrug
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 bagsDrug
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 group | Role | What they receive |
|---|---|---|
| Qishen Yiqi Dripping Pills, 2 bags, take orally half an hour after meals, 3 times a day | Experimental | Not described Receives: Drug: Qishen Yiqi Dripping Pills 2 bags |
| Qishen Yiqi Dripping Pills placebo, 2 bags, take orally half an hour after meals, 3 times a day | Placebo comparator | Not described Receives: Drug: Qishen Yiqi Dripping Pills placebo 2 bags |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 6-minute Walk Distance (6MWD) at Week 12 (Larger Distances Represent Better Exercise Functional Capacity).
Measured: At baseline and at week 12.
Secondary outcomes (16)
Change From Baseline in 6-minute Walk Distance (6MWD) at Week 4 and Week 8.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At baseline and at week 4, week 8 and week 12.
The Number of Participants at Each Level of NYHA Functional Classification and the Proportion of Participants who Improved/Unchanged/Worsened at Week 4, Week 8 and Week 12 Compared With Baseline.
Measured: At baseline and at week 4, week 8 and week 12.
Change From Baseline in Echocardiographic Measures LVEDD (Left Ventricular End Diastolic Diameter) at Week 12.
Measured: At baseline and at week 12.
Change From Baseline in Echocardiographic Measures LVEDV (Left Ventricular End Diastolic Volume) at Week 12.
Measured: At baseline and at week 12.
Change From Baseline in Echocardiographic Measures LVESV (Left Ventricular End Systolic Volume) at Week 12.
Measured: At baseline and at week 12.
Change From Baseline in Echocardiographic Measures LVEF (Left Ventricular Ejection Fraction) at Week 12.
Measured: At baseline and at week 12.
Change From Baseline in Echocardiographic Measures SV (Stroke Volume) at Week 12.
Measured: At baseline and at week 12.
Change From Baseline in Echocardiographic Measures CO (Cardiac Output) at Week 12.
Measured: At baseline and at week 12.
Change From Baseline in N-terminal pro-BNP (NT-proBNP) and log(NT-proBNP) at Week 4, Week 8 and Week 12.
Measured: At baseline and at week 4, week 8 and week 12.
The Proportion of Participants Achieving a Reduction More Than 30% in NT-proBNP at Week 4, Week 8 and Week 12.
Measured: At baseline and at week 4, week 8 and week 12.
Change From Baseline in Grip Strength-Weight Index at Week 4, Week 8 and Week 12.
Measured: At baseline and at week 4, week 8 and week 12.
Events Included in the Composite Endpoint of CV Death and Hospitalization Due to Worsening Heart Failure at Week 4, Week 8 and Week 12.
Measured: At baseline and at week 4, week 8 and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start21 Aug 2026
- Primary completion22 Jun 2028 (estimated)
- Study completion22 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 636 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687186
- Sponsor's protocol ID
- TSL-TCM-QSYQDW-HFrEF-Ⅲ
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No