Qishen Yiqi Dripping Pills improve cardiopulmonary function in post-percutaneous coronary intervention patients

Not Applicable

• Conditions: Cardiovascular protection observed in post-PCI patients with coronary heart disease (CHD); Circulatory System

• Registration Number: ISRCTN83433606
• Lead Sponsor: Chinese Cardiovascular Association TCM Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-09-30
• Last Update Posted: 30 September 2024
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Aged 25-80 years old2. Patients with acute coronary syndrome after coronary interventional treatment 3. Traditional Chinese medicine Qi deficiency and blood stasis certificate (both certificates include: phlegm certificate, Yin deficiency, Yang deficiency certificate)4. Co Cardiopulmonary exercise testing (CPET) contraindications

Exclusion Criteria

1. Serious heart complications such as ventricular septal perforation2. Cardiogenic shock and cardiac arrest3. Vascular interventional treatment success but with vascular lesions with greater than 70% occlusion4. Severe liver and kidney dysfunction, mental abnormalities, hematopoietic dysfunction, co-infection or severe immune system diseases5. Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary function is measured using Cardiopulmonary Exercise Testing at 3 months after PCI

Secondary Outcome Measures

Name	Time	Method
1. Quality of life is measured using the 36-Item Short Form Survey Instrument (SF-36) at baseline, 1, 2 and 3 months after PCI2. Cardiac function is measured using echocardiography at baseline and 3 months after PCI3. Serum inflammatory markers (CRP, IL-6, TNFa, etc.) are measured using chemiluminescence at 3 months after PCI4. Qi deficiency and blood stasis syndrome scores are measured by a Traditional Chinese medicine doctor using Traditional Chinese four ways of diagnosis including looking, listening, questioning and feeling the pulse 3 months after PCI.