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

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

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.

Study Overview

• Status: Unknown
• Conditions: Randomized Controlled Trial; Ginkgo Biloba Extract
• Intervention / Treatment: Drug: Ginkgo biloba pills; Drug: placebo pills

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mingyue Sun, PhD; Phone Number: 008601062835652; Email: sun_moon25@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100091
      • Recruiting
      • Xiyuan Hospital
      • Contact: Yue Liu, PhD; Phone Number: +86 13701167815; Email: liuyueheart@hotmail.com
      • Principal Investigator: Rui Gao, PhD
      • Principal Investigator: Yue Liu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group:Ginkgo biloba pills; Five Ginkgo biloba pills a time and three times a day. One treatment period including 8 weeks.	Drug: 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.
Placebo Comparator: Control group:placebo pills; Five placebo pills a time and three times a day. One treatment period including 8 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fasting plasma glucose (FPG)	changes in blood glucose	8 weeks
postprandial 2h blood glucose (2hPG)	changes in blood glucose	8 weeks
Seattle Angina Questionnaire	Questionnaires will be completed (SAQ - Seattle Angina Questionnaire) at the end of each treatment period. The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and quality of life. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of angina pectoris	Symptoms of angina pectoris, including frequency, duration, attack severity, and the doses of nitroglycerin were recorded, and an angina pectoris symptom score will be calculated. The effect index is determined according to the following formula: Effect index (n) = [(symptom score before treatment - symptom score after treatment) / symptom score before treatment] × 100%. A value of n ≥ 70% suggested a significant effect; 70% >n ≥ 30% suggested an effect; 30% >n ≥ 0 suggested no effect; n < 0 suggested a worsening effect.	8 weeks
C-reactive protein		8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c		8 weeks
fasting insulin		8 weeks
lipids		8 weeks
main adverse cardiovascular and cerebrovascular events(MACCE)	incidence of composite endpoints of major adverse cardiovascular and cerebrovascular events	58 weeks

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Wanbangde Pharmaceutical Group Co., LTD
• Investigators: Study Chair: Rui Gao, PhD, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 25, 2018
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: March 25, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: YXY20180226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No