Herbal dripping pills aim to boost exercise capacity in heart failure

NCT ID NCT07687186

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether Qishen Yiqi Dripping Pills, a traditional Chinese herbal medicine, can improve exercise ability and quality of life in people with chronic heart failure caused by coronary heart disease. The study enrolls adults aged 18 to 80 with reduced heart pumping function (LVEF below 45%) and symptoms of Qi deficiency and blood stasis. Participants take the pills or a placebo three times daily for 12 weeks, and researchers measure changes in how far they can walk in six minutes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Qishen Yiqi Dripping Pills (herbal medicine)
What this could lead to
If effective, this herbal pill could become an add-on treatment to improve exercise capacity and quality of life in people with chronic heart failure.
What could go wrong
This is a single trial testing a specific herbal formula; results may not apply to all heart failure patients. The treatment is added to standard care, so benefits may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 636 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    60 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Chengdu, Sichuan, China

  • Affiliated Hospital of Nanjing University of Chinese Medicine

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, China

  • Affiliated Hospital of North China University of Science and Technology

    NOT_YET_RECRUITING

    Tangshan, Hebei, China

  • Affiliated Hospital of Shaanxi University of Chinese Medicine

    NOT_YET_RECRUITING

    Xianyang, Shaanxi, China

  • Affiliated Hospital of Southwest Medical University

    NOT_YET_RECRUITING

    Luzhou, Sichuan, China

  • Anhui Suzhou Municipal Hospital

    NOT_YET_RECRUITING

    Suzhou, Anhui, China

  • Bozhou People's Hospital

    NOT_YET_RECRUITING

    Bozhou, Anhui, China

  • Chifeng Municipal Hospital

    NOT_YET_RECRUITING

    Chifeng, Neimenggu, China

  • Daqing People's Hospital

    NOT_YET_RECRUITING

    Daqing, Heilongjiang, China

  • First Hospital of Shanxi Medical University

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, China

  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, China

  • Fujian Provincial Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, China

  • Fuwai Yunnan Cardiovascular Hospital

    NOT_YET_RECRUITING

    Kunming, Yunnan, China

  • Gansu Provincial Hospital

    NOT_YET_RECRUITING

    Lanzhou, Gansu, China

  • Guangzhou Red Cross Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

  • Guangzhou University of Chinese Medicine Dongguan Hospital (Dongguan Hospital of Traditional Chinese Medicine)

    NOT_YET_RECRUITING

    Dongguan, Guangdong, China

  • Hebei Provincial Hospital of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, China

  • Hebi People's Hospital

    NOT_YET_RECRUITING

    Hebi, Henan, China

  • Heilongjiang Provincial Hospital

    NOT_YET_RECRUITING

    Harbin, Heilongjiang, China

  • Heze Municipal Hospital

    NOT_YET_RECRUITING

    Heze, Shandong, China

  • Huaihe Hospital of Henan University

    NOT_YET_RECRUITING

    Kaifeng, Henan, China

  • Huangshi Central Hospital

    NOT_YET_RECRUITING

    Huangshi, Hubei, China

  • Jining First People's Hospital

    NOT_YET_RECRUITING

    Jining, Shandong, China

  • Jinzhou Central Hospital

    NOT_YET_RECRUITING

    Jinzhou, Liaoning, China

  • Liaoning Provincial People's Hospital

    NOT_YET_RECRUITING

    Shenyang, Liaoning, China

  • Lishui Central Hospital

    NOT_YET_RECRUITING

    Lishui, Zhejiang, China

  • Liuzhou People's Hospital

    NOT_YET_RECRUITING

    Liuzhou, Guangxi, China

  • Luoyang Third People's Hospital

    NOT_YET_RECRUITING

    Luoyang, Henan, China

  • Mianyang Traditional Chinese Medicine Hospital

    NOT_YET_RECRUITING

    Mianyang, Sichuan, China

  • Panjin Central Hospital

    NOT_YET_RECRUITING

    Panjin, Liaoning, China

  • Pingxiang People's Hospital

    NOT_YET_RECRUITING

    Pingxiang, Jiangxi, China

  • Puyang Oilfield General Hospital

    NOT_YET_RECRUITING

    Puyang, Henan, China

  • Qingyang People's Hospital

    NOT_YET_RECRUITING

    Qingyang, Gansu, China

  • Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, China

  • Shandong Second Provincial People's Hospital

    NOT_YET_RECRUITING

    Jinan, Shandong, China

  • Shiyan People's Hospital

    NOT_YET_RECRUITING

    Shiyan, Hubei, China

  • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, China

  • The First Affiliated Hospital of Guangxi University of Chinese Medicine

    NOT_YET_RECRUITING

    Nanning, Guangxi, China

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Hebei North University

    NOT_YET_RECRUITING

    Zhangjiakou, Hebei, China

  • The First Affiliated Hospital of Henan University

    NOT_YET_RECRUITING

    Kaifeng, Henan, China

  • The First Affiliated Hospital of Hunan University of Chinese Medicine

    NOT_YET_RECRUITING

    Changsha, Hunan, China

  • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

    NOT_YET_RECRUITING

    Hefei, Anhui, China

  • The First Affiliated Hospital of University of South China

    NOT_YET_RECRUITING

    Hengyang, Hunan, China

  • The First Hospital of Hebei Medical University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, China

  • The First People's Hospital of Yulin

    NOT_YET_RECRUITING

    Yulin, Guangxi, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    NOT_YET_RECRUITING

    Xi'an, Shaanxi, China

  • The Second Affiliated Hospital of Xingtai Medical College

    NOT_YET_RECRUITING

    Xingtai, Hebei, China

  • The Second Affiliated Hospital of Zhejiang Chinese Medical University

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

  • The Second Hospital of Lanzhou University

    NOT_YET_RECRUITING

    Lanzhou, Gansu, China

  • The Third Affiliated Hospital of Xinxiang Medical University

    NOT_YET_RECRUITING

    Xinxiang, Henan, China

  • Tianjin Fourth Central Hospital

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, China

  • Wuhan Third Hospital

    NOT_YET_RECRUITING

    Wuhan, Hubei, China

  • Xi'an Daxing Hospital

    NOT_YET_RECRUITING

    Xi'an, Shaanxi, China

  • Xiangya Hospital, Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, China

  • Xingtai Central Hospital

    NOT_YET_RECRUITING

    Xingtai, Hebei, China

  • Xinxiang Central Hospital

    NOT_YET_RECRUITING

    Xinxiang, Henan, China

  • Xiyuan Hospital, China Academy of Chinese Medical Sciences

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Yichang Central People's Hospital

    NOT_YET_RECRUITING

    Yichang, Hubei, China

  • Yuncheng Central Hospital

    NOT_YET_RECRUITING

    Yuncheng, Shanxi, China

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