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

NCT ID: NCT03483779

Last Updated: 2018-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-25
• Study Completion Date: 2021-07-30

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.

Conditions

Randomized Controlled Trial; Ginkgo Biloba Extract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental group:Ginkgo biloba pills

Five Ginkgo biloba pills a time and three times a day. One treatment period including 8 weeks.

Group Type: EXPERIMENTAL

Ginkgo biloba pills

Intervention Type: DRUG

Each N-of-1 trial will consist of 6 treatment periods, of which 2 treatment periods are in one group, including 8 weeks of placebo treatment and 8 weeks of ginkgo biloba pills.

Control group:placebo pills

Five placebo pills a time and three times a day. One treatment period including 8 weeks.

Group Type: PLACEBO_COMPARATOR

placebo pills

Intervention Type: DRUG

Each N-of-1 trial will consist of 6 treatment periods, of which 2 treatment periods are in one group, including 8 weeks of placebo treatment and 8 weeks of ginkgo biloba pills.

Interventions

Ginkgo biloba pills

Each N-of-1 trial will consist of 6 treatment periods, of which 2 treatment periods are in one group, including 8 weeks of placebo treatment and 8 weeks of ginkgo biloba pills.

Intervention Type: DRUG

placebo pills

Each N-of-1 trial will consist of 6 treatment periods, of which 2 treatment periods are in one group, including 8 weeks of placebo treatment and 8 weeks of ginkgo biloba pills.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wanbangde Pharmaceutical Group Co., LTD

INDUSTRY

Sponsor Role: collaborator

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rui Gao, PhD

Role: STUDY_CHAIR

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Locations

Xiyuan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingyue Sun, PhD

Role: CONTACT

sun_moon25@163.com

008601062835652

Facility Contacts

Yue Liu, PhD

Role: primary

liuyueheart@hotmail.com

+86 13701167815

References

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.

Reference Type: DERIVED

PMID: 30405743 (View on PubMed)

Other Identifiers

YXY20180226

Identifier Type: -

Identifier Source: org_study_id