NCT03483779

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Randomized Controlled Trial
• Ginkgo Biloba Extract

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-04-25
• Primary completion: 2020-12-30
• Completion: 2021-07-30
• First posted: 2018-03-30
• Last updated: 2018-04-27

Locations

1 site across 1 country: China