Comparison of the therapeutic effects of 15 mg and 30 mg initial dosage of prednisolone daily in patients with subacute thyroiditis: protocol for a multicenter, randomized, open, parallel control study

Table 1 Study plan detailing the procedures

Study period	Screening	Intervention period
Visit number	1	2	3*	4-x	x	x + n
Study interval	– 0–3 days	Randomization	1 week	Every 1 week	PSL discontinuation	Every 4 weeks
Visit window*			(±2 days)	(±2 days)	(±2 days)	(±7 days)
Telephone visit				√
Screening/Demography/Baseline
Written informed consent	√
Inclusion / Exclusion criteria	√	√
Demographics	√
Physical examination, height, and weight	√
Medical / Current conditions	√
History of diabetes and complications	√
Intervention
Instruction of drugs		√	√	√	√	√
Thyroid pain (VAS)	√	√	√	√	√
Thyroid tenderness	√	√	√	√	√
Temperature monitor	√	√	√	√	√
CRP and ESR	√		√		√
Thyroid function	√				√	√
24 h I-131 uptake or thyroid scintigraphy	√
Hematology panel	√				√
Liver function	√				√
Creatinine, uric acid	√				√
Glucose	√				√
AEs		√	√	√	√	√

AE adverse event, CRP C-reactive protein, ESR erythrocyte sedimentation rate, VAS visual analog scale
*The patients will receive face-to-face daily visit within the first week in research centers; thyroid pain, temperature, and AEs will be assessed at each visit

ISSN: 1745-6215