Integrated Clinical Study of Traditional Chinese and Western Medicine for Refractory Rheumatoid Arthritis
Integrated Clinical Study of Traditional Chinese and Western Medicine for the Treatment of Refractory Rheumatoid Arthritis Using Renowned Traditional Chinese Medicines
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
300 participants
Oct 15, 2025
INTERVENTIONAL
Conditions
Summary
To evaluate the efficacy and safety of Kunxian Capsule combined with Methotrexate and Tofacitinib in the treatment of difficult-to-treat rheumatoid arthritis through a multicenter, randomized, double-blind, placebo-controlled clinical trial, and to identify the therapeutic advantages of integrated Chinese and Western medicine for optimizing the clinical strategy of D2T RA.
Eligibility
Plain Language Summary
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Interventions
Experimental Group (Kunxian Capsule Group + MTX + JAKi): * Kunxian Capsule Placebo: 3 times daily, 0.3-0.6g each time, taken orally after meals; treatment duration: 12 weeks; * Methotrexate: Once weekly, 10-15mg each time, taken orally after meals; treatment duration: 12 weeks; * Tofacitinib: 2 times daily, 1 tablet each time, taken orally; treatment duration: 12 weeks;
Placebo Comparator Group (Kunxian Capsule Placebo Group + MTX + JAKi): * Kunxian Capsule Placebo: 3 times daily, 0.3-0.6g each time, taken orally after meals; treatment duration: 12 weeks; * Methotrexate: Once weekly, 10-15mg each time, taken orally after meals; treatment duration: 12 weeks; * Tofacitinib: 2 times daily, 1 tablet each time, taken orally; treatment duration: 12 weeks;
Locations(1)
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NCT07721142