Efficacy and Safety of Bojungikgi-Tang for Persistent Allergic Rhinitis: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Phase II Trial

Table 1

Schedule of enrollment, interventions, and outcome measurements.

Time point, wk	Screening	Run-in period	Study period
	−2 W	−1 W	0 W	4 W	8 W
Visit	1	2	3	4	5
Enrollment
Informed consent	X
Eligibility screen	X	X
Allocation			X
Demographic characteristics	X
Medical history	X
Chest X-ray, EKG	X
Vital signs	X	X	X	X	X
Interventions
Prescription		X	X	X
High-dose BJIGT
Standard-dose BJIGT
Placebo
Assessments
Clinical laboratory test^(1)	X			X	X
Pregnancy diagnosis test	X				X
MAST	X
TNSS
KARQLQ			X	X	X
Biomarkers^(2)			X		X
Overall assessment					X
Pattern identification			X
Sasang constitution			X
Compliance			X	X	X
Adverse reaction assessment		X	X	X	X

(1) complete blood cell count tests, blood coagulation test, blood chemistry examination (liver and kidney function test), serum hepatitis test, and urine analysis; (2) total IgE, eosinophil count. BJIGT, Bojungikgi-tang; MAST, multiple allergen simultaneous tests; TNSS, total nasal symptoms score; KARQLQ, Korean Allergic Rhinitis-Specific Quality of Life Questionnaire.