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To evaluate the clinical efficacy and safety of Qigi-Tongyang decoction in the treatment of heart failure with preserved ejection fraction of heart and kidney Yang deficiency

To evaluate the clinical efficacy and safety of Qigi-Tongyang decoction in the treatment of heart failure with preserved ejection fraction of heart and kidney Yang deficiency

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000245
Enrollment
Unknown
Registered
2025-02-13
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Heart failure with preserved ejection fraction

Interventions

Treatment group:Conventional western medicine combined with Qigui Tongyang Fang granules
control group:Conventional western medicine treatment

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for heart failure with preserved ejection fraction; 2. In accordance with the diagnostic criteria of heart failure-Yang deficiency of heart and kidney; 3. NYHA class II-III; 4. Age =18 years old and =80 years old, regardless of gender; 5. Understand and agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart failure, acute heart failure, or acute myocardial infarction; (2) Complicated with cardiogenic shock, severe arrhythmia (advanced atrioventricular block, ventricular tachycardia, atrial fibrillation, ventricular fibrillation, etc.), cardiac tamponade, hypertrophic obstructive cardiomyopathy, acute myocarditis, severe heart valve disease with hemodynamic instability, pulmonary embolism, uncontrollable malignant hypertension, and obvious infection; 3. Complicated with serious diseases of liver and kidney, hematopoietic system and endocrine system; 4. Patients with malignant tumors; (5) patients with chronic obstructive pulmonary disease and hypotension; 6. Have mental disorders and unwilling to cooperate; 7. Pregnant, lactating women or women with fertility requirements; 8. Allergic constitution and allergy to the drugs used.

Design outcomes

Primary

MeasureTime frame
Efficacy and classification of cardiac function;TCM syndrome efficacy and score;

Secondary

MeasureTime frame
Blood glucose;Cardiac Biomarkers;Minnesota Quality of Life in Heart Failure Score;Electrocardiogram;Blood lipids;6min walk test and Borg scale;Serum iron ferritin and transferrin;36-item Short form Health Survey;Echocardiography;Uric acid;Homocysteine;

Countries

China

Contacts

Public ContactCaoYu

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

1227173860@qq.com17621777869

Outcome results

None listed

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