Multicenter randomized controlled three-blind study of Qingre Tongbi Pill in the treatment of rheumatoid arthritis with damp-heat stagnation syndrome

INTERVENTION: Treatment group:Methotrexate (MTX) tablets, 10mg/ time, once a week, taken orally at a fixed time every week; Folic acid tablets, 10mg/ time, once a week, taken orally for 24 hours after MTX; Qingre Tongbi Pills, 12 pills/time, twice a day, taken half an hour after breakfast and dinner.;Control group:Methotrexate (MTX) tablets, 10mg/ time, once a week, taken orally at a fixed time every week; Folic acid tablets, 10mg/ time, once a week, taken orally for 24 hours after MTX; Qingre Tongbi Pill Placebo, 12 pills/time, twice a day, taken half an hour after breakfast and dinner.; CONDITION: Rheumatoid arthritis PRIMARY OUTCOME: ACR20/50/70 response rate: the proportion of patients who reached ACR20/50/70 response in the 12th week.; SECONDARY OUTCOME: DAS28 change value: the absolute decline value of joint disease activity score (DAS28 score) from baseline at the 12th and 24th weeks (continuous variable).;Change value of morning stiffness time (minutes, continuous): the minute decline value of Zhou Chen stiffness time in the 12th week and 24th week.;VAS paresthesia score change value (0 10 cm): The VAS paresthesia score (0 10 cm) decreased in the 12th and 24th weeks.;VAS pain score change value (0 10 cm): the VAS pain score (0 10 cm) decreased in the 12th and 24th weeks.; INCLUSION CRITERIA: (1) It conforms to the 2010 ACR/EULAR classification standard for rheumatoid arthritis, and is in the low and middle active stage of the disease (2.6=DAS28 score = 5.1); (2) It meets the diagnostic criteria of damp‐heat stagnation syndrome in traditional Chinese medicine; (3) The patients are between 18 and 60 years old, regardless of sex; (4) Agree and sign the informed consent form.