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Status unknownNCT03483779Updated Apr 27, 2018

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

A Phase 4 interventional study of Ginkgo biloba pills and placebo pills in Randomized Controlled Trial and Ginkgo Biloba Extract, sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-27.

Sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

02

Conditions studied

  • Randomized Controlled Trial
  • Ginkgo Biloba Extract
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In context

Lead sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 43 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
12 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugGinkgo 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.

  • Drugplacebo 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.

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What researchers measure

Primary outcomes

  1. fasting plasma glucose (FPG)

    changes in blood glucose

    Time frame: 8 weeks

  2. postprandial 2h blood glucose (2hPG)

    changes in blood glucose

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. 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.

    Time frame: 8 weeks

  2. C-reactive protein

    Time frame: 8 weeks

Other outcomes

  1. HbA1c

    Time frame: 8 weeks

  2. fasting insulin

    Time frame: 8 weeks

  3. lipids

    Time frame: 8 weeks

  4. main adverse cardiovascular and cerebrovascular events(MACCE)

    incidence of composite endpoints of major adverse cardiovascular and cerebrovascular events

    Time frame: 58 weeks

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Study locations

1 of 1 sites recruiting
  • Xiyuan Hospital
    Beijing, Beijing Municipality 100091, China
    Recruiting
    • Yue Liu, PhD · Contactliuyueheart@hotmail.com · +86 13701167815
    • Rui Gao, PhD · Principal investigator
    • Yue Liu, PhD · Principal investigator
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References and documents

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. PubMed 30405743 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03483779
Lead sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
Wanbangde Pharmaceutical Group Co., LTD
Responsible party
Sponsor
First posted
Mar 30, 2018
Start date
Apr 25, 2018 (estimated)
Primary completion
Dec 30, 2020 (estimated)
Completion
Jul 30, 2021 (estimated)
Last update
Apr 27, 2018

Study contacts

Mingyue Sun, PhD
Contact
sun_moon25@163.com
008601062835652
Rui Gao, PhD
study chair · Xiyuan Hospital of China Academy of Chinese Medical Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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