Wangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900026079

Enrollment

Unknown

Registered

2019-09-20

Start date

2018-10-25

Completion date

Unknown

Last updated

2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Interventions

Experimental group:Wangbi capsule combined methotrexate tablets

Control group:Simulation of Wangbi capsule combined methotrexate tablets

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) meet the diagnostic criteria of ACR/EULAR classification criteria in 2010; (2) Aged 18 and 70 years; (3) DAS28 3.2 to 5.1; (4) RA patients who Compliance with the deficiency of liver and kidney and rheumatism blocked collaterals or phlegm stasis; (5) the subject is informed and voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) osteoarthritis, gout arthritis, reactive arthritis, psoriatic arthritis and arthritis caused by overlapping other connective tissue diseases (such as systemic lupus erythematosus, sjogren's syndrome, scleroderma, etc.); (2) DMARDs other than MTX (including chloroquine, hydroxychloroquine, gold preparation, penicillium amine, sulfanilamide, azathioprine, cyclophosphamide, cyclosporine A, leflunomide, sardoliamine, etc.) were used within 4 weeks before random enrollment; (3) use traditional Chinese medicine (such as tripterygium wilfordii, pavlin, etc.) for the treatment of rheumatoid arthritis within 4 weeks before random enrollment; (4) MTX was used before randomization for less than 3 months, or the dose was not stable at 7.5mg-12.5mg/week for at least 4 weeks; (5) oral glucocorticoid was taken before random enrollment, and the dose (equivalent to the dose of prednisone) was not stable at 10 mg/ d for at least 4 weeks. (6) if NSAIDs was used before random enrollment, the dose was not stable for at least 2 weeks;

Design outcomes

Primary

Measure	Time frame
DAS28;	—

Secondary

Measure	Time frame
Visual Analogue Scale/Score, VAS ;Morning stiffness time;Joint tenderness;ACR20, ACR50, ACR70;TCM syndrome score;HAQ-DI;	—

Countries

China

Contacts

Public ContactSu Li

Longhua Hospital Shanghai University of Traditional Chinese Medicine

suli2002@vip.sina.com+86 18917763085

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026