Status:
UNKNOWN
Comparing Ginkgo Biloba Pills and Placebo in the Treatment of Coronary Heart Disease With Impaired Glucose Regulation
Lead Sponsor:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborating Sponsors:
Wanbangde Pharmaceutical Group Co., LTD
Conditions:
Randomized Controlled Trial
Ginkgo Biloba Extract
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Background Coronary heart disease has become a serious challenge to China with its high prevalence and mortality. The impaired glucose regulation is prevalent in patients with cardiovascular disease....
Eligibility Criteria
Inclusion
- male and female patients with clear history of previous myocardial infarction or history of percutaneous coronary intervention（PCI） or history of coronary artery bypass grafting(CABG) (at least 3 months or more),or who have coronary angiography or coronary CT angiography（CTA） results suggested at least one coronary artery stenosis and lumen stenosis ≥50%,
- in line with the criteria for stable angina, and the number of episodes of angina pectoris ≥ 2 times per week,
- comply with the diagnostic criteria of blood stasis syndrome of coronary heart disease（CHD）,
- comply with the 2016 Diabetes Association (ADA) published criteria for impaired diagnosis of glucose regulation，
- aged between 18 and 75 years，
- participants voluntarily participated in this study, signed informed consent and had good compliance.
Exclusion
- with congenital or rheumatic heart disease or severe cardiopulmonary insufficiency (grade 3 and 4 of cardiac function),or uncontrolled severe arrhythmias (including ventricular tachycardia, supraventricular tachycardia),or not controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure≥ 100 mmHg),
- with cerebrovascular disease,or with severe liver and kidney dysfunction, or with endocrine, urinary, blood system and other serious primary diseases,
- within 4 weeks, there was history of major organ surgery such as head, chest or abdomen or bleeding tendency,
- those who have taken hypoglycaemic agents or glucocorticoids, thiazide diuretics and other drugs that affect blood sugar levels within 3 months,
- people with diseases affecting blood glucose metabolism, such as thyroid glands and adrenal diseases, or those with previous history of the aforementioned diseases,
- allergies or persons allergic to known ingredients of the study drug,
- pregnancy and lactation women or those with a pregnancy plan,
- subjects who participated in other clinical trials in the last 3 months,
- researchers consider that subjects should not participate in clinical trials.
Key Trial Info
Start Date :
April 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03483779
Start Date
April 25 2018
End Date
July 30 2021
Last Update
April 27 2018
Active Locations (1)
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1
Xiyuan Hospital
Beijing, Beijing Municipality, China, 100091