Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre

July 3, 2026 updated by: Tasly Pharmaceutical Group Co., Ltd

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

636

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bozhou, Anhui, China
        • Not yet recruiting
        • Bozhou People's Hospital
        • Contact:
          • Rongyan Jiang
      • Hefei, Anhui, China
        • Not yet recruiting
        • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
        • Contact:
          • Kangyu Chen
      • Suzhou, Anhui, China
        • Not yet recruiting
        • Anhui Suzhou Municipal Hospital
        • Contact:
          • Hailong Qiu
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Not yet recruiting
        • Xiyuan Hospital, China Academy of Chinese Medical Sciences
        • Contact:
          • Guoju Dong
    • Fujian
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Fujian Provincial Hospital
        • Contact:
          • Hui Chen
    • Gansu
      • Lanzhou, Gansu, China
        • Not yet recruiting
        • The Second Hospital of Lanzhou University
        • Contact:
          • Shougang Sun
      • Lanzhou, Gansu, China
        • Not yet recruiting
        • GanSu Provincial Hospital
        • Contact:
          • Yan Zhu
      • Qingyang, Gansu, China
        • Not yet recruiting
        • Qingyang People's Hospital
        • Contact:
          • Wenxia Jia
    • Guangdong
      • Dongguan, Guangdong, China
        • Not yet recruiting
        • Guangzhou University of Chinese Medicine Dongguan Hospital (Dongguan Hospital of Traditional Chinese Medicine)
        • Contact:
          • Xiaohan Ye
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Contact:
          • Zhongqi Yang
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangzhou Red Cross Hospital
        • Contact:
          • Li Li
    • Guangxi
      • Liuzhou, Guangxi, China
        • Not yet recruiting
        • Liuzhou People's Hospital
        • Contact:
          • Yanli Liu
      • Nanning, Guangxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Guangxi University of Chinese Medicine
        • Contact:
          • Xinbing He
      • Yulin, Guangxi, China
        • Not yet recruiting
        • The First People's Hospital of Yulin
        • Contact:
          • Zhengdong Wang
    • Hebei
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
          • Chao Liu
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • Hebei Provincial Hospital of Traditional Chinese Medicine
        • Contact:
          • Yali Feng
      • Tangshan, Hebei, China
        • Not yet recruiting
        • Affiliated Hospital of North China University of Science and Technology
        • Contact:
          • Zhijun Wang
      • Xingtai, Hebei, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Xingtai Medical College
        • Contact:
          • Zhongliang Wang
      • Xingtai, Hebei, China
        • Not yet recruiting
        • Xingtai Central Hospital
        • Contact:
          • Song Zhou
      • Zhangjiakou, Hebei, China
        • Not yet recruiting
        • The First Affiliated Hospital of Hebei North University
        • Contact:
          • Fangjiang Li
    • Heilongjiang
      • Daqing, Heilongjiang, China
        • Not yet recruiting
        • Daqing People's Hospital
        • Contact:
          • Xianyou Ji
      • Harbin, Heilongjiang, China
        • Not yet recruiting
        • Heilongjiang Provincial Hospital
        • Contact:
          • Guimin Wang
    • Henan
      • Hebi, Henan, China
        • Not yet recruiting
        • Hebi People's Hospital
        • Contact:
          • Xueliang Gao
      • Kaifeng, Henan, China
        • Not yet recruiting
        • Huaihe Hospital of Henan University
        • Contact:
          • Yanming Li
      • Kaifeng, Henan, China
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University
        • Contact:
          • Guihong Gong
      • Luoyang, Henan, China
        • Not yet recruiting
        • Luoyang Third People's Hospital
        • Contact:
          • Lipeng Li
      • Puyang, Henan, China
        • Not yet recruiting
        • Puyang Oilfield General Hospital
        • Contact:
          • Dianbo Wang
      • Xinxiang, Henan, China
        • Not yet recruiting
        • Xinxiang Central Hospital
        • Contact:
          • Shuhong Su
      • Xinxiang, Henan, China
        • Not yet recruiting
        • The Third Affiliated Hospital of Xinxiang Medical University
        • Contact:
          • Guotian Yin
    • Hubei
      • Huangshi, Hubei, China
        • Not yet recruiting
        • Huangshi Central Hospital
        • Contact:
          • Daoqun Jin
      • Shiyan, Hubei, China
        • Not yet recruiting
        • Shiyan People's Hospital
        • Contact:
          • Jianing Wang
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Wuhan Third Hospital
        • Contact:
          • Dongsheng Li
      • Yichang, Hubei, China
        • Not yet recruiting
        • Yichang Central People's Hospital
        • Contact:
          • Lin Teng
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Xiangya Hospital, Central South University
        • Contact:
          • Yongping Bai
      • Changsha, Hunan, China
        • Not yet recruiting
        • The First Affiliated Hospital of Hunan University of Chinese Medicine
        • Contact:
          • Wen Zhang
      • Hengyang, Hunan, China
        • Not yet recruiting
        • The First Affiliated Hospital of University of South China
        • Contact:
          • Jie Wu
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Affiliated Hospital of Nanjing University of Chinese Medicine
        • Contact:
          • Chong Zou
    • Jiangxi
      • Pingxiang, Jiangxi, China
        • Not yet recruiting
        • Pingxiang People's Hospital
        • Contact:
          • Yuhong Zhang
    • Liaoning
      • Jinzhou, Liaoning, China
        • Not yet recruiting
        • Jinzhou Central Hospital
        • Contact:
          • Shuai Jiang
      • Panjin, Liaoning, China
        • Not yet recruiting
        • Panjin Central Hospital
        • Contact:
          • Li Li
      • Shenyang, Liaoning, China
        • Not yet recruiting
        • Liaoning Provincial People's Hospital
        • Contact:
          • Aijie Hou
    • Neimenggu
      • Chifeng, Neimenggu, China
        • Not yet recruiting
        • Chifeng Municipal Hospital
        • Contact:
          • Weifang Wang
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Dengfeng Gao
      • Xi'an, Shaanxi, China
        • Not yet recruiting
        • Xi'an Daxing Hospital
        • Contact:
          • Zhili Li
      • Xianyang, Shaanxi, China
        • Not yet recruiting
        • Affiliated Hospital of Shaanxi University of Chinese Medicine
        • Contact:
          • Feng Ji
    • Shandong
      • Heze, Shandong, China
        • Not yet recruiting
        • Heze Municipal Hospital
        • Contact:
          • Jihua Liang
      • Jinan, Shandong, China
        • Not yet recruiting
        • Shandong Second Provincial People's Hospital
        • Contact:
          • Jianqin Feng
      • Jining, Shandong, China
        • Not yet recruiting
        • Jining First People's Hospital
        • Contact:
          • Changjie Ren
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Not yet recruiting
        • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
        • Contact:
          • Xiaolong Wang
    • Shanxi
      • Taiyuan, Shanxi, China
        • Not yet recruiting
        • First Hospital of Shanxi Medical University
        • Contact:
          • Jia Guo
      • Yuncheng, Shanxi, China
        • Not yet recruiting
        • Yuncheng Central Hospital
        • Contact:
          • Yanling Qu
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
        • Contact:
          • Wen Xie
      • Luzhou, Sichuan, China
        • Not yet recruiting
        • Affiliated Hospital of Southwest Medical University
        • Contact:
          • Gang Luo
      • Mianyang, Sichuan, China
        • Not yet recruiting
        • Mianyang Traditional Chinese Medicine Hospital
        • Contact:
          • Zhonggui Liu
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Not yet recruiting
        • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
        • Contact:
          • Xuezheng Liu
      • Tianjin, Tianjin Municipality, China
        • Not yet recruiting
        • Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
        • Contact:
          • Qiang Xu
      • Tianjin, Tianjin Municipality, China
        • Not yet recruiting
        • Tianjin Fourth Central Hospital
        • Contact:
          • Yong Liu
    • Yunnan
      • Kunming, Yunnan, China
        • Not yet recruiting
        • Fuwai Yunnan Cardiovascular Hospital
        • Contact:
          • Lin Sun
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:
          • Liping Dou
      • Lishui, Zhejiang, China
        • Not yet recruiting
        • Lishui Central Hospital
        • Contact:
          • Lingchun Lyu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Qishen Yiqi Dripping Pills, 2 bags, take orally half an hour after meals, 3 times a day
Drug: 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
Placebo Comparator: Qishen Yiqi Dripping Pills placebo, 2 bags, take orally half an hour after meals, 3 times a day
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in 6-minute Walk Distance (6MWD) at Week 12 (Larger Distances Represent Better Exercise Functional Capacity).
Time Frame: At baseline and at week 12.
At baseline and at week 12.

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in 6-minute Walk Distance (6MWD) at Week 4 and Week 8.
Time Frame: At baseline and 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).
Time Frame: At baseline and at week 4, week 8 and week 12.
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.
Time Frame: At baseline and 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).
Time Frame: At baseline and at week 4, week 8 and week 12.
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.
Time Frame: At baseline and at week 4, week 8 and week 12.
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.
Time Frame: At baseline and at week 4, week 8 and week 12.
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.
Time Frame: At baseline and at week 12.
At baseline and at week 12.
Change From Baseline in Echocardiographic Measures LVEDV (Left Ventricular End Diastolic Volume) at Week 12.
Time Frame: At baseline and at week 12.
At baseline and at week 12.
Change From Baseline in Echocardiographic Measures LVESV (Left Ventricular End Systolic Volume) at Week 12.
Time Frame: At baseline and at week 12.
At baseline and at week 12.
Change From Baseline in Echocardiographic Measures LVEF (Left Ventricular Ejection Fraction) at Week 12.
Time Frame: At baseline and at week 12.
At baseline and at week 12.
Change From Baseline in Echocardiographic Measures SV (Stroke Volume) at Week 12.
Time Frame: At baseline and at week 12.
At baseline and at week 12.
Change From Baseline in Echocardiographic Measures CO (Cardiac Output) at Week 12.
Time Frame: At baseline and at week 12.
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.
Time Frame: At baseline and at week 4, week 8 and week 12.
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.
Time Frame: At baseline and at week 4, week 8 and week 12.
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.
Time Frame: At baseline and at week 4, week 8 and week 12.
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.
Time Frame: At baseline and at week 4, week 8 and week 12.
At baseline and at week 4, week 8 and week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tasly Pharmaceutical Group Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 22, 2026

Primary Completion (Estimated)

June 22, 2028

Study Completion (Estimated)

June 22, 2028

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

July 3, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSL-TCM-QSYQDW-HFrEF-Ⅲ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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