Tripterygium Glycoside Tablets Combined With Conventional Synthetic Disease-Modifying Antirheumatic Drugs for Treating Rheumatoid Arthritis: Protocol for a Prospective, Multicenter, Open-Label Randomized Controlled Trial.

This study is examining whether a traditional Chinese herbal medicine called Tripterygium glycoside tablets (TGTs) can effectively treat rheumatoid arthritis when combined with standard medications. Rheumatoid arthritis is a chronic condition that causes painful joint inflammation and swelling. Researchers at three hospitals in China recruited 181 patients with moderately active rheumatoid arthritis and divided them into four groups. One group received TGTs alone, while the other three groups received TGTs combined with different conventional medications: methotrexate, leflunomide, or hydroxychloroquine. The study tracked patients for 12 weeks, measuring pain levels, disease activity, quality of life, and any side effects. Importantly, this study is still ongoing—while patient enrollment is complete, the researchers are currently organizing their data and have not yet analyzed the results. The findings are expected to be published by the end of 2026. This research is significant because TGTs are considered a cost-effective treatment option, but doctors need better evidence about which medication combinations work best. The results will help healthcare providers understand whether adding TGTs to standard arthritis medications provides better relief than using TGTs alone, and which combination might be most effective for managing moderate rheumatoid arthritis symptoms. If you're interested in traditional Chinese medicine approaches to arthritis management, consult with a qualified, licensed acupuncturist or integrative medicine practitioner who can discuss appropriate treatment options for your specific condition.

This multicenter, open-label randomized controlled trial is evaluating the efficacy and safety of Tripterygium glycoside tablets (TGTs) as monotherapy and in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for moderate rheumatoid arthritis. The study enrolled 181 patients across three hospitals, randomized 1:1:1:1 to receive TGT monotherapy, TGT plus methotrexate, TGT plus leflunomide, or TGT plus hydroxychloroquine over 12 weeks. Primary outcome is ACR20 response rate; secondary outcomes include DAS28-ESR, DAS28-CRP, CDAI, SDAI, pain VAS, and HAQ-DI. The study represents a protocol publication—recruitment concluded December 2025, with data collection complete but statistical analysis pending. Results are anticipated by end of 2026. This trial addresses a significant evidence gap regarding optimal TGT-based combination therapy for RA, with intention-to-treat analysis planned. The research provides needed data on cost-effective csDMARD combinations in moderate disease activity.