Herbal dripping pills aim to boost exercise capacity in heart failure
NCT ID NCT07687186
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 636 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
60 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
NOT_YET_RECRUITINGChengdu, Sichuan, China
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Affiliated Hospital of Nanjing University of Chinese Medicine
NOT_YET_RECRUITINGNanjing, Jiangsu, China
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Affiliated Hospital of North China University of Science and Technology
NOT_YET_RECRUITINGTangshan, Hebei, China
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Affiliated Hospital of Shaanxi University of Chinese Medicine
NOT_YET_RECRUITINGXianyang, Shaanxi, China
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Affiliated Hospital of Southwest Medical University
NOT_YET_RECRUITINGLuzhou, Sichuan, China
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Anhui Suzhou Municipal Hospital
NOT_YET_RECRUITINGSuzhou, Anhui, China
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Bozhou People's Hospital
NOT_YET_RECRUITINGBozhou, Anhui, China
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Chifeng Municipal Hospital
NOT_YET_RECRUITINGChifeng, Neimenggu, China
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Daqing People's Hospital
NOT_YET_RECRUITINGDaqing, Heilongjiang, China
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First Hospital of Shanxi Medical University
NOT_YET_RECRUITINGTaiyuan, Shanxi, China
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First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, China
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Fujian Provincial Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, China
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Fuwai Yunnan Cardiovascular Hospital
NOT_YET_RECRUITINGKunming, Yunnan, China
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Gansu Provincial Hospital
NOT_YET_RECRUITINGLanzhou, Gansu, China
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Guangzhou Red Cross Hospital
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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Guangzhou University of Chinese Medicine Dongguan Hospital (Dongguan Hospital of Traditional Chinese Medicine)
NOT_YET_RECRUITINGDongguan, Guangdong, China
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Hebei Provincial Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITINGShijiazhuang, Hebei, China
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Hebi People's Hospital
NOT_YET_RECRUITINGHebi, Henan, China
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Heilongjiang Provincial Hospital
NOT_YET_RECRUITINGHarbin, Heilongjiang, China
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Heze Municipal Hospital
NOT_YET_RECRUITINGHeze, Shandong, China
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Huaihe Hospital of Henan University
NOT_YET_RECRUITINGKaifeng, Henan, China
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Huangshi Central Hospital
NOT_YET_RECRUITINGHuangshi, Hubei, China
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Jining First People's Hospital
NOT_YET_RECRUITINGJining, Shandong, China
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Jinzhou Central Hospital
NOT_YET_RECRUITINGJinzhou, Liaoning, China
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Liaoning Provincial People's Hospital
NOT_YET_RECRUITINGShenyang, Liaoning, China
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Lishui Central Hospital
NOT_YET_RECRUITINGLishui, Zhejiang, China
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Liuzhou People's Hospital
NOT_YET_RECRUITINGLiuzhou, Guangxi, China
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Luoyang Third People's Hospital
NOT_YET_RECRUITINGLuoyang, Henan, China
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Mianyang Traditional Chinese Medicine Hospital
NOT_YET_RECRUITINGMianyang, Sichuan, China
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Panjin Central Hospital
NOT_YET_RECRUITINGPanjin, Liaoning, China
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Pingxiang People's Hospital
NOT_YET_RECRUITINGPingxiang, Jiangxi, China
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Puyang Oilfield General Hospital
NOT_YET_RECRUITINGPuyang, Henan, China
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Qingyang People's Hospital
NOT_YET_RECRUITINGQingyang, Gansu, China
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Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, China
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Shandong Second Provincial People's Hospital
NOT_YET_RECRUITINGJinan, Shandong, China
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Shiyan People's Hospital
NOT_YET_RECRUITINGShiyan, Hubei, China
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Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, China
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The First Affiliated Hospital of Guangxi University of Chinese Medicine
NOT_YET_RECRUITINGNanning, Guangxi, China
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The First Affiliated Hospital of Guangzhou University of Chinese Medicine
RECRUITINGGuangzhou, Guangdong, China
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The First Affiliated Hospital of Hebei North University
NOT_YET_RECRUITINGZhangjiakou, Hebei, China
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The First Affiliated Hospital of Henan University
NOT_YET_RECRUITINGKaifeng, Henan, China
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The First Affiliated Hospital of Hunan University of Chinese Medicine
NOT_YET_RECRUITINGChangsha, Hunan, China
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The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
NOT_YET_RECRUITINGHefei, Anhui, China
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The First Affiliated Hospital of University of South China
NOT_YET_RECRUITINGHengyang, Hunan, China
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The First Hospital of Hebei Medical University
NOT_YET_RECRUITINGShijiazhuang, Hebei, China
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The First People's Hospital of Yulin
NOT_YET_RECRUITINGYulin, Guangxi, China
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The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITINGXi'an, Shaanxi, China
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The Second Affiliated Hospital of Xingtai Medical College
NOT_YET_RECRUITINGXingtai, Hebei, China
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The Second Affiliated Hospital of Zhejiang Chinese Medical University
NOT_YET_RECRUITINGHangzhou, Zhejiang, China
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The Second Hospital of Lanzhou University
NOT_YET_RECRUITINGLanzhou, Gansu, China
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The Third Affiliated Hospital of Xinxiang Medical University
NOT_YET_RECRUITINGXinxiang, Henan, China
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Tianjin Fourth Central Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, China
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Wuhan Third Hospital
NOT_YET_RECRUITINGWuhan, Hubei, China
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Xi'an Daxing Hospital
NOT_YET_RECRUITINGXi'an, Shaanxi, China
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Xiangya Hospital, Central South University
NOT_YET_RECRUITINGChangsha, Hunan, China
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Xingtai Central Hospital
NOT_YET_RECRUITINGXingtai, Hebei, China
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Xinxiang Central Hospital
NOT_YET_RECRUITINGXinxiang, Henan, China
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Xiyuan Hospital, China Academy of Chinese Medical Sciences
NOT_YET_RECRUITINGBeijing, Beijing Municipality, China
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Yichang Central People's Hospital
NOT_YET_RECRUITINGYichang, Hubei, China
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Yuncheng Central Hospital
NOT_YET_RECRUITINGYuncheng, Shanxi, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The impact of video-based cardiac rehabilitation education in patients with cardiovascular implantable electronic Devices(CIEDs)- a randomized controlled trial
- Effect of the use of dapagliflozin in diuresis, natriuresis and in ultrafiltration and peritoneal elimination of sodium, in patients with refractory heart failure
- Can a 10-Week coaching program ease the toll on heart failure caregivers?
- Can a 10-Second chest scan reveal hidden heart clues?
- Can AI help nurses guide At-Risk seniors to better care and lower costs?
- A Body-Scan test may reveal hidden fluid buildup, guiding early diuretic use