Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Active Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Topical compound tripterygium

Study type: Interventional

Funder types: Other

Identifiers

NCT01961505

Z111107058811104

Details and patient eligibility

About

Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium wilfordii Hook F has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a prospective randomized controlled study to evaluated the efficacy and safety of external application with compound Tripterygium wilfordii Hook F in treating of patients with rheumatoid arthritis (RA).

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria or European League Against Rheumatism criteria (2009).
• Patients must have moderately to severely active RA,and the DAS-28 score should be from 3.2 to 5.1.
• If taking disease modifying antirheumatic drug (DMARDs)(e.g.Methotrexate), subject must have been on a stable dose for ≥ 3 months prior to randomization.
• If taking non-steroidal anti-inflammatory drugs (NSAIDs), subject must have been on a stable dose for ≥ 4 weeks prior to randomization.
• 16 to 65 years old, having signed the informed consent.

Exclusion criteria

• Patients who have skin burst or allergies.
• Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system.
• Patients who have been treated by tripterygium, hormones or biological agents.
• Patients who have not been treated by DMARDs before.
• Patients who are unwilling to comply with all study procedures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Topical Tripterygium group

Experimental group

Description:

Patients were treated with topical compound tripterygium for 1 hour, twice per day. Area dosages were as followed that each 1st to 5th metacarpophalangeal joints (MCPJs), 1st to 5th proximal interphalangeal joints (PIPJs) and wrist was 3 ml, each elbow and ankle was 5 ml, each knee was 10 ml.

Treatment:

Drug: Topical compound tripterygium

Topical Placebo group

Placebo Comparator group

Description:

Patients were treated with topical placebo for 1 hour, twice per day. The dosage was the same as the topical tripterygium group.

Treatment:

Drug: Placebo