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A randomized, double-blind controlled study of Kuoxinfang in the treatment on Deficiency of both Qi and Yin combined blood stasis with dilated cardiomyopathy

A multicenter randomized controlled clinical study of Kuoxin Decoction of heart failure in dilated cardiomyopathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068937
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Dilated cardiomyopathy

Interventions

Control group:Kuoxinfang granule placebo combined with conventional western medicine

Sponsors

Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of Western medicine and traditional Chinese medicine for dilated cardiomyopathy; 2. NYHA was grade II-IV; 3. Aged 45-80 years; 4. Left ventricle Left ventricular ejection fraction (LVEF) <=45%; 5. Agree to participate in clinical trial observation, sign informed consent and indicate the date.

Exclusion criteria

Exclusion criteria: 1. History of acute myocardial infarction, coronary stent implantation and coronary artery bypass grafting; Patients with severe arrhythmias such as ventricular tachycardia, grade II type II atrioventricular block, pulmonary embolism, shock and other life-threatening diseases; 2. Patients with severe hepatic and renal insufficiency, hyperthyroidism, hypothyroidism, anemia and electrolyte imbalance; 3. Pregnant and lactating patients; 4. Patients with serious medical diseases, such as respiratory system, digestive system, blood system, immune system, or diseases that may cause serious danger to patients; 5. Allergic constitution or allergy to common drugs; 6. Recently participated in other TCM clinical researchers or are currently taking other TCM regularly and do not want to stop taking; 7. Patients with mental illness or poor compliance with traditional Chinese medicine treatment.

Design outcomes

Primary

MeasureTime frame
Clinical efficacy and improvement of cardiac function;

Secondary

MeasureTime frame
Evaluation of the efficacy of TCM syndrome;Cardiac Doppler ultrasound;

Countries

China

Contacts

Public ContactWang Youhua
doctorwyh@163.com+86 158 2172 5508

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026