Clinical trial NCT03483779: Comparing Ginkgo Biloba Pills and Placebo in the Treatment of Coronary Heart Disease With Impaired Glucose Regulation
Official title: A Series of N-of-1 Trials of Comparing Ginkgo Biloba Pills and Placebo in the Treatment of Coronary Heart Disease With Impaired Glucose Regulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Randomized Controlled Trial
Ginkgo Biloba Extract
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Wanbangde Pharmaceutical Group Co., LTD
First posted: 2018-03-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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 Criteria:

1. 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%,
2. in line with the criteria for stable angina, and the number of episodes of angina pectoris ≥ 2 times per week,
3. comply with the diagnostic criteria of blood stasis syndrome of coronary heart disease（CHD）,
4. comply with the 2016 Diabetes Association (ADA) published criteria for impaired diagnosis of glucose regulation，
5. aged between 18 and 75 years，
6. participants voluntarily participated in this study, signed informed consent and had good compliance.

Exclusion Criteria:

1. 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),
2. with cerebrovascular disease,or with severe liver and kidney dysfunction, or with endocrine, urinary, blood system and other serious primary diseases,
3. within 4 weeks, there was history of major organ surgery such as head, chest or abdomen or bleeding tendency,
4. those who have taken hypoglycaemic agents or glucocorticoids, thiazide diuretics and other drugs that affect blood sugar levels within 3 months,
5. people with diseases affecting blood glucose metabolism, such as thyroid glands and adrenal diseases, or those with previous history of the aforementioned diseases,
6. allergies or persons allergic to known ingredients of the study drug,
7. pregnancy and lactation women or those with a pregnancy plan,
8. subjects who participated in other clinical trials in the last 3 months,
9. researchers consider that subjects should not participate in clinical trials.

Primary outcomes:
measure: fasting plasma glucose (FPG)
timeFrame: 8 weeks
measure: postprandial 2h blood glucose (2hPG)
timeFrame: 8 weeks
measure: Seattle Angina Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: Symptoms of angina pectoris
timeFrame: 8 weeks
measure: C-reactive protein
timeFrame: 8 weeks
Other outcomes:
measure: HbA1c
timeFrame: 8 weeks
measure: fasting insulin
timeFrame: 8 weeks
measure: lipids
timeFrame: 8 weeks
measure: main adverse cardiovascular and cerebrovascular events(MACCE)
timeFrame: 58 weeks
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital
state: Beijing
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Rui Gao, PhD
role: STUDY_CHAIR
References:
citation: Sun M, Chai L, Lu F, Zhao Y, Li Q, Cui B, Gao R, Liu Y. Efficacy and Safety of Ginkgo Biloba Pills for Coronary Heart Disease with Impaired Glucose Regulation: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Placebo-Controlled Trials. Evid Based Complement Alternat Med. 2018 Oct 14;2018:7571629. doi: 10.1155/2018/7571629. eCollection 2018.