RecruitingPhase 2Phase 3NCT07627893

Complementary Herbal Approach to Rheumatoid Management Study (CHARMS)

Sponsor

Singapore General Hospital

Enrollment

132 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)

Summary

Rheumatoid Arthritis (RA) is a chronic disease characterised by symmetric, polyarticular pain and swelling, involving small joints of the hands and feet. RA can lead to irreversible joint damage without treatment, causing disability and impacting daily activities and work productivity. Some patients turn to Chinese Herbal Medication (CHM) for treatment. Since there is currently no well designed randomised controlled trial to support the 'real-world' use of Si Miao Xiao Bi Tang with anti-rheumatic drugs, such as methotrexate, the investigators are conducting a 12-week, randomised double-blinded placebo-controlled trial to determine the efficacy, safety and cost effectiveness of a modified Si Miao Xiao Bi Tang, a type of CHM, in the treatment of patients with active RA.

Eligibility

Min Age: 21 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Methotrexate, Shu Bi Ning (modified Si Miao Xiao Bi), and others for people with rheumatoid arthritis (ra). The study is currently recruiting participants at 1 location. People eligible for this study include aged 21 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

OTHERShu Bi Ning (modified Si Miao Xiao Bi)

Shu Bi Ning (modified Si Miao Xiao Bi) is a chinese herbal medication for treatment of damp-heat syndrome.

DRUGMethotrexate

Patients receive standard dose of oral methotrexate that is ordered by their attending rheumatologist.

OTHERShu Bi Ning placebo

Placebo granules will be manufactured with no new herbal components (all herbal content is HSA certified). Placebo granules will comprise of 5% of the herbal components (using Modified Si Miao Xiao Bi), 95% black bean powder and 0.05% denatonium benzoate will be added as a bitterant. This is to ensure that the placebo possesses similar taste and smell of the herbal components. The placebo will be colour adjusted to match actual herbal granules, and the packaging for the herbal and placebo granules will be done using the same packaging material to ensure both are similar in appearance.