Efficacy and Safety of Wenbu Zhibi Granule in Patients with Ankylosing Spondylitis: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Table 1

Screening criteria of participants.

Inclusion criteria	Exclusion criteria
Diagnosed with AS according to the revised New York standards [18]	Total spinal ankylosis
Having active disease indicated by BASDAI score ≥4	Other rheumatic diseases such as SLE, RA
Older than 18 and the age of first onset was less than 45	Other serious diseases of vital organs
Consenting to the use of effective contraception during the trial period	Pregnancy or lactation
Voluntary participating in this study, adopting by the ethics committee, ensuring the test compliance and signing the informed consent	Cancer, cognitive, or mental disorders
	Suspected or confirmed history of alcohol abuse
	Infection and severe allergic reactions
	Active systemic infection within 2 weeks before the baseline visit
	Abnormal laboratory indexes of liver and kidney function

AS: ankylosing spondylitis; BASDAI: bath ankylosing spondylitis disease activity index; SLE: systemic lupus erythematosus; RA: rheumatoid arthritis.