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A randomized controlled trial of csDMARDs combined with Tripterygium glycoside tablets in the treatment of rheumatoid arthritis

A randomized controlled trial of csDMARDs combined with Tripterygium glycoside tablets in the treatment of rheumatoid arthritis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088173
Enrollment
Unknown
Registered
2024-08-13
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Rheumatoid arthritis

Interventions

Tripterygium wilfordii group:Tripterygium glycoside tablets alone
Tripterygium + methotrexate group:Tripterygium glycoside tablets + methotrexate tablets
Tripterygium + leflunomide group:Tripterygium glycoside tablets + leflunomide tablets
Tripterygium + hydroxychloroquine group:Tripterygium glycoside tablets + hydroxychloroquine sulfate tablets

Sponsors

Dongzhimen Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? 18 ~ 65 years old;? 5.1=DAS28 > 3.2;?Men or women who have no reproductive requirements;? Patients who did not participate in any clinical trial within 4 weeks before enrollment;? The patient gives informed consent and signs the informed consent.

Exclusion criteria

Exclusion criteria: ? There are serious organ diseases or mental diseases; ? Patients who can not adhere to medication for 12 weeks due to various reasons; ? Patients with sjogren's syndrome, ankylosing spondylitis, systemic lupus erythematosus, dermatomyositis and other rheumatic diseases; ? Liver and kidney insufficiency; Pregnant or lactating women (breastfeeding); ? Patients with severe gastrointestinal ulcer or active gastrointestinal bleeding; ? Patients with glucocorticoids or biologics.

Design outcomes

Primary

MeasureTime frame
ACR20 response rate;DAS 28-ESR and CRP response rate;

Secondary

MeasureTime frame
CDAI;SDAI;VAS;PGA;MDGA;SF-36;HAQ-DI;TNF-a; IL-6;Adverse event rate;

Countries

China

Contacts

Public ContactLV LIU

Dongzhimen Hospital, Beijing University of Chinese Medicine

984193184@qq.com+86 186 0108 1300

Outcome results

None listed

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