Comparing Ginkgo Biloba Pills and Placebo in the Treatment of Coronary Heart Disease With Impaired Glucose Regulation

Phase

Condition

Myocardial Ischemia

Atherosclerosis

Heart Disease

Treatment

N/A

Clinical Study ID

NCT03483779

YXY20180226

Ages 18-75
All Genders

Study 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. However, there are few drugs that interfere early with impaired glucose regulation. Ginkgo biloba extract is not only a commonly used drug for cardiovascular diseases, but also has a significant effect in reducing blood sugar. Therefore, this study used a single case randomized controlled trial to explore the efficacy of Ginkgo biloba pills in the treatment of coronary heart disease patients with impaired glucose regulation.

Methods

This is a randomized, double-blind, placebo-controlled, three-period crossover trial for a single subject.A total of 12 subjects will be recruited in this trial. The trial is divided into three cycles, one cycle has two treatment periods. Ginkgo biloba pills and placebo will be randomized during the treatment period. The test period will be lasted 58 weeks and subjects will take 48 weeks. Subjects will be selected by the researcher strictly in accordance with the inclusion and exclusion criteria.

Eligibility Criteria

Inclusion

Inclusion Criteria:

male and female patients with clear history of previous myocardial infarction orhistory of percutaneous coronary intervention（PCI） or history of coronary arterybypass grafting(CABG) (at least 3 months or more),or who have coronary angiography orcoronary CT angiography（CTA） results suggested at least one coronary artery stenosisand lumen stenosis ≥50%,
in line with the criteria for stable angina, and the number of episodes of anginapectoris ≥ 2 times per week,
comply with the diagnostic criteria of blood stasis syndrome of coronary heartdisease（CHD）,
comply with the 2016 Diabetes Association (ADA) published criteria for impaireddiagnosis of glucose regulation，
aged between 18 and 75 years，
participants voluntarily participated in this study, signed informed consent and hadgood compliance.

Exclusion

Exclusion Criteria:

with congenital or rheumatic heart disease or severe cardiopulmonary insufficiency (grade 3 and 4 of cardiac function),or uncontrolled severe arrhythmias (includingventricular 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 withendocrine, urinary, blood system and other serious primary diseases,
within 4 weeks, there was history of major organ surgery such as head, chest orabdomen or bleeding tendency,
those who have taken hypoglycaemic agents or glucocorticoids, thiazide diuretics andother drugs that affect blood sugar levels within 3 months,
people with diseases affecting blood glucose metabolism, such as thyroid glands andadrenal 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.

Study Design

April 25, 2018

July 30, 2021

Connect with a study center

Xiyuan Hospital
Beijing, Beijing 100091
China
Active - Recruiting

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