Improvement of Shen'ge Formula on Heart Function in Diastolic Heart Failure: a Randomized, Double-Blind, Placebo-Controlled Clinical Study

Phase 1

• Conditions: diastolic heart failure

• Registration Number: ITMCTR2000003661
• Lead Sponsor: onghua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who meet the diagnostic criteria of Western medicine and traditional Chinese medicine;
2. Patients with NYHA grade II-IV cardiac function;
3. Patients aged 18-80 years;
4. Patients who are not taking forbidden medicine and could complete the trial;
5. Patients who participate in this clinical trial voluntarily, understand and sign the informed consent.

Exclusion Criteria

1. Combine shock, acute myocardial infarction, pulmonary embolism, infectious endocarditis, pericarditisserious Hepatic and renal insufficiency
2. Pregnant or lactating women and patients with mental disorder
3. Seriously ill patients with life expectancy less than 6 months
4. Patients who are taking other traditional Chinese Medicine and unwilling to stop

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T-proBNP;

Secondary Outcome Measures

Name	Time	Method
Traditional Chinese Medicine score;Minnesota heart failure quality of life score;echocardiography;NYHA heart function grade;cardiopulmonary exercise testing;