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Taking people in ChinaPhase 3

Tests Qishen Yiqi Dripping Pills in adults with heart failure from coronary heart disease

Tests Qishen Yiqi Dripping Pills against a placebo in adults with reduced-function heart failure.

Key facts

Who runs it
Tasly Pharmaceutical Group Co., Ltd
Where
Beijing, Bozhou, Changsha, Chengdu, Chifeng, Daqing, Dongguan, Fuzhou, Guangzhou, Hangzhou, Harbin, Hebi, Hefei, Hengyang, Heze, Huangshi, Jinan, Jining, Jinzhou, Kaifeng, Kunming, Lanzhou, Lishui, Liuzhou, Luoyang, Luzhou, Mianyang, Nanjing, Nanning, Panjin, Pingxiang, Puyang, Qingyang, Shanghai, Shenyang, Shijiazhuang, Shiyan, Suzhou, Taiyuan, Tangshan, Tianjin, Wuhan, Xi'an, Xi’an, Xianyang, Xingtai, Xinxiang, Yichang, Yulin, Yuncheng, and Zhangjiakou, ChinaSee the 60 sites
Trial code
Registry title
Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre
Status
Recruiting
Phase
Phase 3
People taking part
636 people, planned
Started
21 Aug 2026
Expected to end
22 Jun 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Qishen Yiqi Dripping Pills 2 bags
  • Qishen Yiqi Dripping Pills placebo 2 bags
Record updated
23 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 80 with long-term heart failure caused by coronary heart disease. Their heart must pump out less blood than normal.

Age
18 to 80 years
Sex
Women and men can both join.
Disease stage
Chronic heart failure with coronary heart disease, NYHA class II-III, left ventricular ejection fraction (LVEF) below 45%, and the Chinese medicine pattern of Qi deficiency with blood stasis.
Earlier treatment
Must have had standard heart failure drug treatment for at least 2 weeks before randomization, with no dose change. No intravenous treatment (vasoactive drugs, diuretics) in the last 2 weeks.

Main reasons for not taking part

  • Heart failure caused by other heart or non-heart diseases
  • Heart attack, revascularization, device or heart surgery, or stroke in the last 3 months
  • Uncontrolled high blood pressure, low blood pressure, or severe rhythm problems
  • Abnormal liver or kidney tests, HbA1c 9.0% (75 mmol/mol) or higher, hemoglobin below 90 g/L, or potassium above 5.5 mmol/L
  • Pregnant or breastfeeding women, or allergy to the Qishen Yiqi ingredients

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • 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 take part

  • 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)
  • 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 participated in other interventional drug clinical trials within 1 month before screening
  • 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)
  • 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
  • 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
  • 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
  • Had absolute contraindications for the 6-minute walk test or was unable to complete the 6-minute walk test
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in China

  • Xiyuan Hospital, China Academy of Chinese Medical SciencesBeijing, ChinaContact: Guoju DongNot yet recruiting
  • Bozhou People's HospitalBozhou, ChinaContact: Rongyan JiangNot yet recruiting
  • The First Affiliated Hospital of Hunan University of Chinese MedicineChangsha, ChinaContact: Wen ZhangNot yet recruiting
  • Xiangya Hospital Central South UniversityChangsha, ChinaContact: Yongping BaiNot yet recruiting
  • Affiliated Hospital of Chengdu University of Traditional Chinese MedicineChengdu, ChinaContact: Wen XieNot yet recruiting
  • Chifeng Municipal HospitalChifeng, ChinaContact: Weifang WangNot yet recruiting
  • Daqing People's HospitalDaqing, ChinaContact: Xianyou JiNot yet recruiting
  • Guangzhou University of Chinese Medicine Dongguan Hospital (Dongguan Hospital of Traditional Chinese Medicine)Dongguan, ChinaContact: Xiaohan YeNot yet recruiting
  • Fujian Provincial HospitalFuzhou, ChinaContact: Hui ChenNot yet recruiting
  • Guangzhou Red Cross HospitalGuangzhou, ChinaContact: Li LiNot yet recruiting
  • The First Affiliated Hospital of Guangzhou University of Chinese MedicineGuangzhou, ChinaContact: Zhongqi YangTaking people
  • The Second Affiliated Hospital of Zhejiang Chinese Medical UniversityHangzhou, ChinaContact: Liping DouNot yet recruiting
  • Heilongjiang Provincial HospitalHarbin, ChinaContact: Guimin WangNot yet recruiting
  • Hebi People's HospitalHebi, ChinaContact: Xueliang GaoNot yet recruiting
  • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)Hefei, ChinaContact: Kangyu ChenNot yet recruiting
  • The First Affiliated Hospital of University of South ChinaHengyang, ChinaContact: Jie WuNot yet recruiting
  • Heze Municipal HospitalHeze, ChinaContact: Jihua LiangNot yet recruiting
  • Huangshi Central HospitalHuangshi, ChinaContact: Daoqun JinNot yet recruiting
  • Shandong Second Provincial People's HospitalJinan, ChinaContact: Jianqin FengNot yet recruiting
  • Jining First People's HospitalJining, ChinaContact: Changjie RenNot yet recruiting
  • Jinzhou Central HospitalJinzhou, ChinaContact: Shuai JiangNot yet recruiting
  • Huaihe Hospital of Henan UniversityKaifeng, ChinaContact: Yanming LiNot yet recruiting
  • The First Affiliated Hospital of Henan UniversityKaifeng, ChinaContact: Guihong GongNot yet recruiting
  • Fuwai Yunnan Cardiovascular HospitalKunming, ChinaContact: Lin SunNot yet recruiting
  • Gansu Provincial HospitalLanzhou, ChinaContact: Yan ZhuNot yet recruiting
  • The Second Hospital of Lanzhou UniversityLanzhou, ChinaContact: Shougang SunNot yet recruiting
  • Lishui Central HospitalLishui, ChinaContact: Lingchun LyuNot yet recruiting
  • Liuzhou People's HospitalLiuzhou, ChinaContact: Yanli LiuNot yet recruiting
  • Luoyang Third People's HospitalLuoyang, ChinaContact: Lipeng LiNot yet recruiting
  • Affiliated Hospital of Southwest Medical UniversityLuzhou, ChinaContact: Gang LuoNot yet recruiting
  • Mianyang Traditional Chinese Medicine HospitalMianyang, ChinaContact: Zhonggui LiuNot yet recruiting
  • Affiliated Hospital of Nanjing University of Chinese MedicineNanjing, ChinaContact: Chong ZouNot yet recruiting
  • The First Affiliated Hospital of Guangxi University of Chinese MedicineNanning, ChinaContact: Xinbing HeNot yet recruiting
  • Panjin Central HospitalPanjin, ChinaContact: Li LiNot yet recruiting
  • Pingxiang People's HospitalPingxiang, ChinaContact: Yuhong ZhangNot yet recruiting
  • Puyang Oilfield General HospitalPuyang, ChinaContact: Dianbo WangNot yet recruiting
  • Qingyang People's HospitalQingyang, ChinaContact: Wenxia JiaNot yet recruiting
  • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineShanghai, ChinaContact: Xiaolong WangNot yet recruiting
  • Liaoning Provincial People's HospitalShenyang, ChinaContact: Aijie HouNot yet recruiting
  • Hebei Provincial Hospital of Traditional Chinese MedicineShijiazhuang, ChinaContact: Yali FengNot yet recruiting
  • The First Hospital of Hebei Medical UniversityShijiazhuang, ChinaContact: Chao LiuNot yet recruiting
  • Shiyan People's HospitalShiyan, ChinaContact: Jianing WangNot yet recruiting
  • Anhui Suzhou Municipal HospitalSuzhou, ChinaContact: Hailong QiuNot yet recruiting
  • First Hospital of Shanxi Medical UniversityTaiyuan, ChinaContact: Jia GuoNot yet recruiting
  • Affiliated Hospital of North China University of Science and TechnologyTangshan, ChinaContact: Zhijun WangNot yet recruiting
  • First Teaching Hospital of Tianjin University of Traditional Chinese MedicineTianjin, ChinaContact: Xuezheng LiuNot yet recruiting
  • Second Affiliated Hospital of Tianjin University of Traditional Chinese MedicineTianjin, ChinaContact: Qiang XuNot yet recruiting
  • Tianjin Fourth Central HospitalTianjin, ChinaContact: Yong LiuNot yet recruiting
  • Wuhan Third HospitalWuhan, ChinaContact: Dongsheng LiNot yet recruiting
  • The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaContact: Dengfeng GaoNot yet recruiting
  • Xi'an Daxing HospitalXi’an, ChinaContact: Zhili LiNot yet recruiting
  • Affiliated Hospital of Shaanxi University of Chinese MedicineXianyang, ChinaContact: Feng JiNot yet recruiting
  • The Second Affiliated Hospital of Xingtai Medical CollegeXingtai, ChinaContact: Zhongliang WangNot yet recruiting
  • Xingtai central hospitalXingtai, ChinaContact: Song ZhouNot yet recruiting
  • The Third Affiliated Hospital of Xinxiang Medical UniversityXinxiang, ChinaContact: Guotian YinNot yet recruiting
  • Xinxiang Central HospitalXinxiang, ChinaContact: Shuhong SuNot yet recruiting
  • Yichang Central People's HospitalYichang, ChinaContact: Lin TengNot yet recruiting
  • The First people's hospital of YulinYulin, ChinaContact: Zhengdong WangNot yet recruiting
  • Yuncheng Central HospitalYuncheng, ChinaContact: Yanling QuNot yet recruiting
  • The First Affiliated Hospital of Hebei North UniversityZhangjiakou, ChinaContact: Fangjiang LiNot yet recruiting

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Qishen Yiqi Dripping Pills, 2 bags, take orally half an hour after meals, 3 times a dayTreatment being tested

    Treatment: Qishen Yiqi Dripping Pills 2 bags

  • Qishen Yiqi Dripping Pills placebo, 2 bags, take orally half an hour after meals, 3 times a dayPlacebo, for comparison

    Treatment: Qishen Yiqi Dripping Pills placebo 2 bags

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Tests Qishen Yiqi Dripping Pills in adults with heart failure from coronary heart diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07687186, who can take part
Record updated
23 October 2026