Observation on the Efficacy of Shenge Powder on the Patients of Chronic Heart Failure

Phase 1

• Conditions: Chronic heart failure

• Registration Number: ITMCTR2100005159
• Lead Sponsor: anxiang Hospital

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. Western medicine diagnostic criteria: have a history of coronary heart disease, and meet the above-mentioned diagnostic criteria for chronic heart failure;
2. TCM diagnostic criteria: formulated with reference to the relevant content of Shanghai Traditional Chinese Medicine Diseases and Syndrome Diagnosis and Treatment Routine (Second Edition), namely main symptoms: palpitations, shortness of breath and fatigue, asthma with movement, conscious fear of cold, and low temperature of hands and feet. Secondary symptoms: oliguria and edema, abdominal distension, loose stools, and pale complexion. Tongue pulse: The tongue is fat or has tooth marks, and the pulse is thin or late. The main symptoms must have 2 items, and the secondary symptoms have 2 items. Combined with the tongue and pulse, the diagnosis can be established;
3. Age: 45 to 85 years old;
4. Cardiac function classification: according to the New York Heart Association (NYHA) cardiac function classification method, the cardiac function is II to III.

Exclusion Criteria

1. Those with bronchial asthma, chronic bronchitis, pulmonary heart disease, chronic obstructive pulmonary disease;
2. Those with unstable blood pressure control;
3. Patients with acute cardiac insufficiency;
4. Patients with severe liver and kidney dysfunction and heart failure due to failure of important organs such as kidney and liver;
5. Patients with serious primary diseases such as endocrine system and hematopoietic system;
6. Pregnant or lactating women;
7. Those with allergic constitution or history of allergies;
8. Patients with mental disorders and unwilling to cooperate; patients with poor compliance, and those who interrupt the treatment before the prescribed observation period cannot judge the curative effect.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
TCM symptom score;Six minute walking test (6MWT);NYHA functional classification;

Secondary Outcome Measures

Name	Time	Method
High-sensitivity C-reactive protein;Brain natriuretic peptide;Interleukin-6;Cystatin C;High-Sensitivity Troponin T;Homocysteine;Nuclear factor kappa-B;Electrocardiogram;Quality of life assessment;TCM Syndrome Score;Echocardiography;Tumor necrosis factor-a(TNF-a);