Observation of the curative effect of Guizhi-Shaoyao-Zhimu decoction combined with methotrexate in the treatment of early rheumatoid arthritis based on ultrasonic evaluation: study protocol of a randomized, double-blind, controlled clinical trial

Table 1 Schedule of study procedures

		Study period
	Enrolment	Allocation	Post-allocation (days)				Close-out *90d+*
Time point	*- -T0d*	*-T0d*	*T0d*	*T30d*	*T60d*	*T90d*
Enrolment
Patients with early RA	X
RF	X
Diagnosis and investigation of the distribution of TCM syndrome types	X
Informed consent	X
General information	X
General physical examination	X
Allocation		X
Interventions
Western medicine as well as TCM placebo combined group			X	X	X	X
Western medicine as well as TCM combined group			X	X	X	X
Assessments
Blood routine			X	X	X	X
Urine routines			X			X
Hepatic and renal function (ALT, AST, AKP, eGFR, Scr, BUN)			X	X	X	X
TCM symptoms			X	X	X	X
ESR, CRP			X	X	X	X
DAS28, VAS			X	X	X	X
US7			X			X
sCD14, MMP3, TIMP1			X			X
Adverse events			X	X	X	X

A total of 152 participants will be randomized into the control group or the experimental group. Assessors blinded to the randomization will collect data during the intervention period at baseline and at study months 1, 2, and 3. The peripheral blood levels of matrix metalloproteinase 3 (MMP3), matrix metalloprotease 1 (TIMP1), and soluble cluster of differentiation 14 (sCD14) will be detected before and after treatment to explore the biochemical mechanisms of Guizhi-Shaoyao-Zhimu decoction for the treatment of active RA

ISSN: 1745-6215