Table 1 Inclusion and exclusion criteria of the trial

► Age 18–75 years

► Meeting the 1987 ACR or 2010 ACR/EULAR diagnostic criteria

► Meeting the diagnostic criteria for “kidney deficiency and dampness” and “stasis blocking channels” in Chinese medicine

► DAS28 score of 2.6 to 3.2

► Regularly taking methotrexate (7.5–15 mg qw) and tofacitinib (5 mg bid) before enrollment and stable treatment regimen for more than 12 weeks

► Voluntary participation and signed written informed consent

► Patients taking immunosuppressive drugs other than methotrexate and tofacitinib within 3 months prior to enrollment

► Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST > 3 times the normal upper limit), kidney (Ccr < 60 ml/min) and other important organ function impairment or hematological system diseases

► Psychiatric disorders such as cognitive disorders, depression, anxiety disorders, somatic dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating lesions and other central neurological disorders, or peripheral neurological disorders such as restless legs syndrome. peripheral neurological disorders such as restless legs syndrome

► Women and men who are pregnant or breastfeeding or who are planning a pregnancy within the next 6 months; during the trial or within 1 month of the last dose Women of childbearing age who are unable or unwilling to use adequate contraception, or whose spouse is unwilling to use contraception, within 1 month of the last dose or within 1 month of the last dose are unwilling to use contraception

► Persons with a BMI greater than 35 (kg/m²), allergic to the test drug, or participating in other clinical trials

► Other conditions deemed by the investigator to be inappropriate for trial participation (out-of-town patients unable to be followed up, etc.)