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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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ClinicalTrials.gov Identifier: NCT03483779
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
WanBangDe Pharmaceutical Group Co.,Ltd.
Information provided by (Responsible Party):
Xiyuan Hospital of China Academy of Chinese Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Randomized Controlled Trial Ginkgo Biloba Extract Drug: Ginkgo biloba pills Drug: placebo pills Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 25, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. fasting plasma glucose (FPG) [ Time Frame: 8 weeks ]
    changes in blood glucose

  2. postprandial 2h blood glucose (2hPG) [ Time Frame: 8 weeks ]
    changes in blood glucose

  3. Seattle Angina Questionnaire [ Time Frame: 8 weeks ]

    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 :
  1. Symptoms of angina pectoris [ Time Frame: 8 weeks ]

    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.


  2. C-reactive protein [ Time Frame: 8 weeks ]

Other Outcome Measures:
  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) [ Time Frame: 58 weeks ]
    incidence of composite endpoints of major adverse cardiovascular and cerebrovascular events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483779


Contacts
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Contact: Mingyue Sun, PhD 008601062835652 sun_moon25@163.com

Locations
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China, Beijing
Xiyuan Hospital Recruiting
Beijing, Beijing, China, 100091
Contact: Yue Liu, PhD    +86 13701167815    liuyueheart@hotmail.com   
Principal Investigator: Rui Gao, PhD         
Principal Investigator: Yue Liu, PhD         
Sponsors and Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
WanBangDe Pharmaceutical Group Co.,Ltd.
Investigators
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Study Chair: Rui Gao, PhD Xiyuan Hospital of China Academy of Chinese Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xiyuan Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03483779    
Other Study ID Numbers: YXY20180226
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases