Clinical assessment of complementary treatment with Qishen Yiqi Dripping Pills on ischemic heart failure(CACT-IHF): A Randomized, Double-blind, Multicenter, Placebo-controlled Trial

Clinical assessment and promotion of TCM differential diagnosis and treatment program for ischemic heart failure

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001863

Enrollment

Unknown

Registered

2011-12-30

Start date

2011-12-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic heart failure

Interventions

treatment group:One packet of Qishen Yiqi Dripping Pills (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications only

control group:One packet of Qishen Yiqi Dripping Pills dummy (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications

Eligibility

Sex/Gender

All

Age

40 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Age 40 to 79; 2. Patients with ischemic heart failure: (1) LVEF less than or equal to 45% measured by echocardiography in modified Simpson method; (2) History of prior myocardial infarction with or without percutaneous coronary intervention (PCI) or/and coronary artery bypass grafting (CABG); (3) Coronary angiography (CAG) or coronary CTA shows more than or equal to 50% stenosis in at least one of the main coronary arteries with or without revascularization, of which the researcher thinks that it is closely related to heart failure; (4) With or without dyspnea, fatigue and fluid retention (edema) etc.; (5) History of heart failure or present with heart failure symptoms for at least 3 months; (6) New York Heart Association (NYHA) Class II to IV; (7) Submitted informed consent.

Exclusion criteria

Exclusion criteria: 1. Acute heart failure or acute exacerbation of chronic heart failure; 2. Those who have one of the following diseases: 3. Acute coronary syndrome within 30 days; 4. Revascularization therapy within 6 months; 5. Uncontrolled hypertension with systolic pressure more than or equal to 180mmHg and/or diastolic pressure more than or equal to 110mmHg; 6. Second degree type 2 or worse sinoatrial /atrioventricular block without implantation of pacemaker or uncontrolled malignant cardiac arrhythmia; 7. Dilated cardiomyopathy ; 8. Hypertrophic obstructive cardiomyopathy; 9. Myocarditis; 10. Pulmonary artery embolism; 11. Severe valvular heart disease; 12. Pulmonary heart disease; 13. Stroke within 6 months; 14. Cardiac resynchronization therapy; 15. Applied diuretics, cardiotonic agents or vasodilators intravenously within 7 days; 16. Severe endocrine diseases such as hyperthyroidism, etc. 17. History of malignant tumor; 18. Hemoglobin (HB) 2 times the upper limit of normal; 20. Serum creatinine > 265umol/L; 21. Mental disorder; 22. Being pregnant, planning for pregnancy or breastfeeding; 23. Suspicious or definite allergy to intervention drugs; 24. Participated in other trials within 2 months; 25. Unable to walk autonomously due to physical disabilities.

Design outcomes

Primary

Measure	Time frame
6MWT distance;	—

Secondary

Measure	Time frame
Composite endpoint: all-cause death, frequency of emergency/re-admission to hospital due to HF;Brain natriuretic peptide (BNP);Echocardiography;Cardiothoracic Ratio(CR);Cardiac function classification, NYHA;Minnesota life quality scale;Scores from the four TCM diagnostic method;	—

Countries

China

Contacts

Public ContactJingyuan Mao

jymao@126.com+86 022 27432325

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026