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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

Rui Liu contact

022-86343626

liurui2@tasly.com

60 sites in 1 country

China60 sites, 60 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

    Not yet recruiting

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong

    Zhongqi Yang

    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

    Not yet recruiting

Other trials in China

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 groups in NCT07687186
Study groupRoleWhat they receive
Qishen Yiqi Dripping Pills, 2 bags, take orally half an hour after meals, 3 times a dayExperimentalNot 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 dayPlacebo comparatorNot 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.

  1. 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)

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Change From Baseline in Echocardiographic Measures LVEDD (Left Ventricular End Diastolic Diameter) at Week 12.

    Measured: At baseline and at week 12.

  8. Change From Baseline in Echocardiographic Measures LVEDV (Left Ventricular End Diastolic Volume) at Week 12.

    Measured: At baseline and at week 12.

  9. Change From Baseline in Echocardiographic Measures LVESV (Left Ventricular End Systolic Volume) at Week 12.

    Measured: At baseline and at week 12.

  10. Change From Baseline in Echocardiographic Measures LVEF (Left Ventricular Ejection Fraction) at Week 12.

    Measured: At baseline and at week 12.

  11. Change From Baseline in Echocardiographic Measures SV (Stroke Volume) at Week 12.

    Measured: At baseline and at week 12.

  12. Change From Baseline in Echocardiographic Measures CO (Cardiac Output) at Week 12.

    Measured: At baseline and at week 12.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  1. First posted7 Jul 2026
  2. Study start21 Aug 2026
  3. Primary completion22 Jun 2028 (estimated)
  4. Study completion22 Jun 2028 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rui Liu (022-86343626, liurui2@tasly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07687186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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