RecruitingPhase 4NCT07721142

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


Sponsor

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Enrollment

300 participants

Start Date

Oct 15, 2025

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Kunxian Capsule and a drug called Kunxian Capsule Placebo for people with rheumatoid arthritis (ra). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKunxian Capsule

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;

DRUGKunxian Capsule Placebo

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)

Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, China

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NCT07721142


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