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A Multi-Centered Randomized Double-Blinded Parallel Controlled Clinical Study on Efficacy of Warming the Kidney, Invigorating the Spleen, Activating Blood and Removing Edema Method in the Treatment of Chronic Heart Failure

A Multi-Centered Randomized Double-Blinded Parallel Controlled Clinical Study on Efficacy of Warming the Kidney, Invigorating the Spleen, Activating Blood and Removing Edema Method in the Treatment of Chronic Heart Failure

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036154
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-31

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

Conditions

chronic heart failure

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 to 74years; 2. Those who meet the diagnostic criteria of Western medicine;and with II to III degree of the cardiac function stardand of New York Heart Association; 3. Those whose BNP content >= 150pg/ml(or Pro-BNP >= 600pg/ml); 4. Those whose the left ventricular ejection fraction (LVEF) was <= 40%; 5. Those who meet the syndrome differentiation of TCM; 6. Those who participate in this clinical trial voluntarily, understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Combine the serious primary disorders; 2. Combine serious infection; 3. Plan to accept Cardiac surgical procedures; 4. Critical patients who may cannot survive to the end of the trial; 5. Pregnant or lactating women; 6. Allergic Constitution, allergic to many kinds of medicine; 7. Patients with mental disorder and unwilling to cooperate; 8. Other conditions that are not suitable for participation in clinical trials.

Design outcomes

Primary

MeasureTime frame
NYHA grade;the total score of TCM syndrome;

Secondary

MeasureTime frame
6-minute walking test;Minnesota heart failure quality of life score;EF;LAD;LVEDD;Plasma BNP;Plasma pro-BNP;Readmission rate;Kansas City Cardiomyopathy Questionnaire;

Countries

China

Contacts

Public ContactYan Shen

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine

sheny26@126.com+86 021-65161782

Outcome results

None listed

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