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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
12
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.
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.
Xiyuan Hospital
Beijing, Beijing Municipality, China
RECRUITINGfasting plasma glucose (FPG)
changes in blood glucose
Time frame: 8 weeks
postprandial 2h blood glucose (2hPG)
changes in blood glucose
Time frame: 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.
Time frame: 8 weeks
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
C-reactive protein
Time frame: 8 weeks
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