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
试验速览
- 阶段
- 4 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- fasting plasma glucose (FPG)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental group:Ginkgo biloba pills
Five Ginkgo biloba pills a time and three times a day. One treatment period including 8 weeks.
干预措施: Ginkgo biloba pills (Drug)
Control group:placebo pills
Five placebo pills a time and three times a day. One treatment period including 8 weeks.
干预措施: placebo pills (Drug)
结局指标
主要结局
fasting plasma glucose (FPG)
时间窗: 8 weeks
changes in blood glucose
postprandial 2h blood glucose (2hPG)
时间窗: 8 weeks
changes in blood glucose
Seattle Angina Questionnaire
时间窗: 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.
次要结局
- C-reactive protein(8 weeks)
- Symptoms of angina pectoris(8 weeks)