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

Primary Purpose

Randomized Controlled Trial, Ginkgo Biloba Extract

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Ginkgo biloba pills

placebo pills

About this trial

This is an interventional treatment trial for Randomized Controlled Trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Xiyuan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group:Ginkgo biloba pills

Control group:placebo pills

Arm Description

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

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

Outcomes

Primary Outcome Measures

fasting plasma glucose (FPG)

changes in blood glucose

postprandial 2h blood glucose (2hPG)

changes in blood glucose

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.

Secondary Outcome Measures

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.

C-reactive protein

Full Information

NCT ID

NCT03483779

First Posted

March 25, 2018

Last Updated

April 25, 2018

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Collaborators

Wanbangde Pharmaceutical Group Co., LTD

1. Study Identification

Unique Protocol Identification Number

NCT03483779

Brief Title

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

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 25, 2018 (Anticipated)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Collaborators

Wanbangde Pharmaceutical Group Co., LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Randomized Controlled Trial, Ginkgo Biloba Extract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group:Ginkgo biloba pills

Arm Type

Experimental

Arm Description

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

Arm Title

Control group:placebo pills

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ginkgo biloba pills

Intervention Description

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

Intervention Name(s)

placebo pills

Intervention Description

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.

Primary Outcome Measure Information:

Title

fasting plasma glucose (FPG)

Description

changes in blood glucose

Time Frame

8 weeks

Title

postprandial 2h blood glucose (2hPG)

Description

changes in blood glucose

Time Frame

8 weeks

Title

Seattle Angina Questionnaire

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Symptoms of angina pectoris

Description

Time Frame

8 weeks

Title

C-reactive protein

Time Frame

8 weeks

Other Pre-specified Outcome Measures:

Title

HbA1c

Time Frame

8 weeks

Title

fasting insulin

Time Frame

8 weeks

Title

lipids

Time Frame

8 weeks

Title

main adverse cardiovascular and cerebrovascular events(MACCE)

Description

incidence of composite endpoints of major adverse cardiovascular and cerebrovascular events

Time Frame

58 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mingyue Sun, PhD

Phone

008601062835652

sun_moon25@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rui Gao, PhD

Organizational Affiliation

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

Xiyuan Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100091

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yue Liu, PhD

Phone

+86 13701167815

liuyueheart@hotmail.com

First Name & Middle Initial & Last Name & Degree

Rui Gao, PhD

First Name & Middle Initial & Last Name & Degree

Yue Liu, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

30405743

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.

Results Reference

derived

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

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