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
		Enrolment	Allocation	Post allocation						Close-out
				Cycle 1		Cycle 2		Cycle 3
	Time Point	D-7 to D-0	0	Weeks 1-10	Weeks 11-20	Weeks 21-30	Weeks 31-40	Weeks 41-50	Weeks 51-58	Week 58
Enrollment	EligibilityScreen
	Informed consent
	Allocation
Intervention	Intervention Ginkgo biloba drop pills or Ginkgo biloba drop pills simulant
Assessment	Baseline 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.