Evidence-Based Complementary and Alternative Medicine / 2018 / Article / Tab 1

Research Article

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

Table 1

N-of-1 test for the treatment of coronary heart disease with impaired glucose regulation using Ginkgo biloba drop pills and simulant.

Study Period

EnrolmentAllocationPost allocationClose-out

Cycle 1Cycle 2Cycle 3

Time PointD-7 to D-00Weeks 1-10Weeks 11-20Weeks 21-30Weeks 31-40Weeks 41-50Weeks 51-58Week 58

EnrollmentEligibilityScreen
Informed consent
Allocation

InterventionIntervention Ginkgo biloba drop pills or Ginkgo biloba drop pills simulant

AssessmentBaseline variables
Urine pregnancy test for women of childbearing age
Physical examination
Blood routine, urine routine, liver function, renal function, vital signs, ECG
Blood glucose, blood lipids, SAQ, the angina symptom score, C-reactive protein

Note. The trial consisted of three cycles and was divided into six treatment periods. Patients receiving Ginkgo biloba drop pills and placebo treatment were randomized. There are 8 weeks for each treatment period and a 2-week washout period at the end of treatment.

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