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Clinical efficacy and experimental mechanism of traditional Chinese medicine formula granules (Xinlikang granules) in the treatment of heart failure

Clinical efficacy and experimental mechanism of traditional Chinese medicine formula granules (Xinlikang granules) in the treatment of heart failure

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098945
Enrollment
Unknown
Registered
2025-03-17
Start date
2024-11-08
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Heart Failure

Interventions

Sponsors

Nanyang Second General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of coronary heart disease and heart failure in Western medicine: Have a history of coronary heart disease leading to heart failure or risk factors for coronary heart disease; Have obvious signs or symptoms of heart failure; NYHA cardiac function classification belongs to grade II-IV. Left ventricular ejection fraction (LVEF) =450 pg/mL. (2) Complying with the TCM syndrome differentiation standard of Yang deficiency and blood stasis. (3) Aged from 18 to 80 (including boundary value). (4) Grade II to IV (NYHA cardiac functional classification). (5) Good mental state able to communicate barrier-free. (6) Informed consent signed.

Exclusion criteria

Exclusion criteria: (1) Heart failure caused by liver-kidney and other important organ. (2) Women who are pregnant and lactating, people with mental disorders and those who are unwilling to cooperate. (3) Patients with severe liver and kidney dysfunction, electrolyte disorders and serious primary diseases of the endocrine system, hematopoietic system etc. (4) Patients with combined shock, severe arrhythmia, complete atrioventricular block, obstructive cardiomyopathy, unrepaired valvular disease, constrictive pericarditis, pulmonary embolism, implanted cardiac pacemakers and other ventricular assist devices, obvious infection and uncontrolled hypertension. (5) Those who have a clear history of allergy to the drugs used in this study. (6) Those who have participated in other clinical trials within 3 months. (7) Those who cannot perform the 6-minute walk test due to limb disability or other reasons.

Design outcomes

Primary

MeasureTime frame
Minnesota Heart Failure Quality of Life Questionnaire;NYHA cardiac function grading;Traditional Chinese Medicine,TCM syndrome integration;

Secondary

MeasureTime frame
NT-proBNP;6-minute walking distance;Related parameters measured by cardiac ultrasound;Long term prognosis;

Countries

China

Contacts

Public ContactLv Shuzhi

Nanyang Second General Hospital

1134509506@qq.com+86 138 3775 8416

Outcome results

None listed

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