Comparing Ginkgo Biloba Pills and Placebo in the Treatmen... | NCT03483779

Status Module

Name	Class
Wanbangde Pharmaceutical Group Co., LTD	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ginkgo biloba pills	Drug	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

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.

Name	Role	Phone	Extension	Email
Mingyue Sun, PhD	Contact	008601062835652		sun_moon25@163.com

Name	Affiliation	Role
Rui Gao, PhD	Xiyuan Hospital of China Academy of Chinese Medical Sciences	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Xiyuan Hospital	Recruiting	Beijing	Beijing Municipality	100091	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30405743	Derived	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.