A randomized double-blind controlled clinical study on the effects of qishen yiqi dropping pills on exercise endurance and quality of life in patients with coronary heart disease after interventional therapy

Phase 4

Recruiting

• Conditions: Postoperative coronary heart disease

• Registration Number: ITMCTR2100004678
• Lead Sponsor: China-Japan Friendship 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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Have a clear understanding of the research content and purpose, participate in the study voluntarily, and sign the informed consent form by himself / herself;
2. It is consistent with the diagnostic criteria of Western medicine for stable coronary heart disease;
3. Patients with Qi deficiency and blood stasis syndrome who meet the above diagnostic criteria of TCM;
4. Complete the overall treatment plan after PCI;
5. Within 1 week to 6 months after PCI;
6. The age is between 18 and 75 years old.

Exclusion Criteria

1. There are contraindications of cardiopulmonary exercise test;
2. Plan for coronary artery bypass grafting or heart transplantation;
3. Within 3 months before admission: stroke, transient ischemic attack; carotid artery or other major vascular surgery; persistent ventricular tachycardia or ventricular fibrillation;
4. Ventricular arrhythmia was not controlled effectively (antiarrhythmic drugs or implantable defibrillator were ineffective;
5. Uncorrected primary obstruction or severe reflux valvular disease, non dilated (restrictive) or hypertrophic cardiomyopathy;
6. Patients with second or third degree heart block or sick sinus syndrome, without permanent pacemaker, who need implantable devices for heart failure;
7. Obstructive or bronchospasmodic lung disease (such as asthma, bronchitis, etc.) requires oral or inhaled bronchodilator or hormone therapy;
8. Pregnant or lactating women and women who plan to become pregnant during the trial period;
9. Cancer or other systemic diseases, the expected survival time is less than 12 months;
10. Use other clinical trial drugs or participate in medical device test within 30 days before enrollment;
11. The researchers considered that they could not participate in the study after clinical evaluation.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Peak oxygen consumption change rate;

Secondary Outcome Measures

Name	Time	Method
Indexes of systolic and diastolic function in echocardiography;Liver and kidney function;seattle angina questionnaire;EuroQol-5 Dimensions;TCM syndrome score;electrocardiogram;blood fat;routine blood test;