Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial

Table 2

Schedule for enrollment, intervention, and assessment.

Activity	Phase	Screen/enroll	Allocation	Treatment/intervention				Intervention end	Follow-up
	Time points	Week 0		Weeks 1-2	Weeks 3-4	Weeks 5-6	Weeks 7-8		Week 12	Week 16
Screening/enrollment	Eligibility screening	●	●
	Acquisition of informed consent	●
	Clinicopathological evaluation	●
	Medical history recorded	●
	Enrollment	●
	Random allocation		●
	Biological specimen collection		●	●	●	●	●	●	●	●
Treatment/intervention	Basic treatment + JYKL		★-------------------------------------------------------------------------★
	Basic treatment + placebo granules		☆-------------------------------------------------------------------------☆
Outcome assessment	PASI score	●	●	●	●	●	●	●	●	●
	Affected BSA	●	●	●	●	●	●	●	●	●
	PGA score	●	●	●	●	●	●	●	●	●
	DLQI score		●	●	●	●	●	●		●
	QOL score		●	●	●	●	●	●		●
	VAS score		●	●	●	●	●	●	●	●
	CM syndrome		●	●	●	●	●	●		●
	Recurrence								●	●
Safety assessment	Vital signs	●	●	●	●	●	●	●		●
	BR	●					●	●		●
	BB	●					●	●		●
	RUT	●					●	●		●
	DC	●	●	●	●	●	●	●		●
	PT	●
	PE	●					●	●		●
	AEs		●	●	●	●	●	●		●
	Severe AEs		●	●	●	●	●	●		●

✩, intervention in the control group; ★, intervention in the experimental group; ●, what needs to be done in the corresponding time period. JYKL, Jueyin granules; PASI, Psoriasis Area and Severity Index; BSA, body surface area; PGA, physician global assessment; DLQI, dermatology life quality index; QOL, quality of life; VAS, Visual Analogue Scale; CM, Chinese medicine; BR, blood routine; BB, blood biochemistry; RUT, routine urine test; DC, drug combination; PT, pregnancy test; PE, physical examination; AE, adverse event.