Clinical Study of Qixuetongzhi Formula Improving The Prognosis of Stable Coronary Heart Disease

Phase 1

• Conditions: stable coronary heart disease

• Registration Number: ITMCTR2200005893
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

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)Coronary angiography or coronary computed tomographic angiography shows at least one major coronary artery luminal diameter stenosis = 50% or a history of myocardial infarction, or be in stable condition more than one month after percutaneous coronary intervention or coronary artery bypass grafting.
(2)Left ventricular ejection fraction = 40%.
(3)Canadian Cardiovascular Society grading of angina pectoris I-II.
(4)Traditional Chinese Medicine syndrome of qi deficiency and blood stasis, liver qi stagnation.
(5)Aged 18-75 years.
(6)Meet low to medium risk stratification of cardiac rehabilitation, and could take part in cardiopulmonary exercise test;
(7) Provide written informed consent.

Exclusion Criteria

(1)Acute myocardial infarction, unstable angina pectoris, underwent PCI or CABG within the past one month.
(2)Meet absolute and relative contraindications of CPET.
(3)Patients who have taken drugs for tonifying qi or promoting blood circulation or regulating qi, or have participated in other clinical trials during the past month.
(4)Renal insufficiency, serum creatinine >2.5 mg/dl (220umo/l) in males and >2.0 mg/dl (175umo/l) in females.
(5)Patients with severe liver disease and/or alanine aminotransferase, aspartate transaminase >3 times the upper limit of normal.
(6)New York Heart Association class ? or recurrent malignant arrhythmia.
(7)Complicated with chronic obstructive pulmonary disease, pulmonary infection, or respiratory failure.
(8)Diabetic patients with random blood glucose =13.7mmol/L or glycosylated hemoglobin =9.5%.
(9)Pregnancy, preparing for pregnancy and breastfeeding.
(10)Patients with acute cerebrovascular disease, malignant tumour, life expectancy less than 1 year, serious hematopoietic system disease.
(11)Patients with psychosis or PHQ-9 or GAD-7 scale score = 15 or those who have taken anti-anxiety and depression drugs within the past 1 month;
(12)Patients who are allergy to known ingredients of the study drug.

Study & Design

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