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Xiefei Lishui Formula treating chronic ischemic heart failure: A randomized, double-blind, placebo-controlled clinical study

Xiefei Lishui Formula treating chronic ischemic heart failure: A randomized, double-blind, placebo-controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000962
Enrollment
Unknown
Registered
2026-04-16
Start date
2025-11-08
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Chronic Ischemic Heart Failure

Interventions

Experimental Group:Xiefei Lishui Formula granules

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Those who voluntarily participate in the clinical study and sign the informed consent form; 2. Those who signed the informed consent form were aged 18 years or above, with no gender restrictions; 3. They meet the Western medical diagnostic criteria for chronic heart failure, with LVEF 70%); ii. Have a history of coronary revascularization (percutaneous transluminal coronary angioplasty + stent implantation / coronary artery bypass grafting); iii. Have a history of old myocardial infarction; 4. NYHA class II to III; 5. TCM diagnosis belongs to qi deficiency and blood stasis, or water retention and internal stagnation syndrome.

Exclusion criteria

Exclusion criteria: 1. Those who had experienced acute coronary syndrome, stroke, transient cerebral ischemic attack or undergone cardiac surgery such as PCI or CABG within 3 months prior to enrollment; 2. Those who plan to undergo cardiac surgery such as PCI or CABG or cardiac resynchronization therapy (CRT) during the trial period; 3. Those with heart failure caused by other reasons, including heart valve diseases, congenital heart diseases, hypertrophic cardiomyopathy, pericardial diseases, arrhythmogenic cardiomyopathy, myocarditis or other non-cardiac factors; 4. Those with severe liver function abnormalities (ALT or AST higher than 2 times the upper limit of normal) or renal function abnormalities (Cr > 3 mg/dl or 265.2 µmol/L); 5. Those with poor blood pressure control, defined as systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg, or systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 60 mmHg; 6. Those with severe pulmonary hypertension, malignant tumors, mental disorders, etc.; 7. Those with contraindications to the 6-minute walk test or unable to complete the 6-minute walk test; 8. Those who have participated in other clinical studies in the past 1 month; 9. Those who have taken similar efficacy traditional Chinese medicine preparations or similar drugs within the past 2 weeks.

Design outcomes

Primary

MeasureTime frame
Improvement rate of LVEF;

Secondary

MeasureTime frame
NT-proBNP;6min walk distance;TCM syndrome score and therapeutic effect;Kansas City Cardiomyopathy Questionnaire Score (KCCQ-23);Major cardiovascular adverse event (MACE);

Countries

China

Contacts

Public ContactLai Xiaolei

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

laixiaolei@bjzhongyi.com135 8156 1063

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026