NCT03483779

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

April 25, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

April 27, 2018

Status Verified

February 1, 2018

Enrollment Period

2.7 years

First QC Date

March 25, 2018

Last Update Submit

April 25, 2018

Conditions

Randomized Controlled TrialGinkgo Biloba Extract

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Symptoms of angina pectoris

    8 weeks

  • C-reactive protein

    8 weeks

Other Outcomes (4)

  • HbA1c

    8 weeks

  • fasting insulin

    8 weeks

  • lipids

    8 weeks

  • +1 more other outcomes

Study Arms (2)

Experimental group:Ginkgo biloba pills

EXPERIMENTAL

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

Drug: Ginkgo biloba pills

Control group:placebo pills

PLACEBO COMPARATOR

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

Drug: placebo pills

Interventions

Ginkgo biloba pillsDRUG

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.

Experimental group:Ginkgo biloba pills
placebo pillsDRUG

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiyuan Hospital

Beijing, Beijing Municipality, 100091, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30405743DERIVED

Study Officials

  • Rui Gao, PhD

    Xiyuan Hospital of China Academy of Chinese Medical Sciences

    STUDY CHAIR

Central Study Contacts

Mingyue Sun, PhD

CONTACT

008601062835652sun_moon25@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2018

First Posted

March 30, 2018

Study Start

April 25, 2018

Primary Completion

December 30, 2020

Study Completion

July 30, 2021

Last Updated

April 27, 2018

Record last verified: 2018-02

Locations

CN(1)