Active Rheumatoid Arthritis
Conditions
Brief summary
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).
Interventions
DRUGTopical compound tripterygium
Topical compound tripterygium was applied for the pain and swollen joints on non-woven fabric for 1 hour, twice per day.
DRUGPlacebo
The topical placebo recipe composes viscous agent which matches by the sucrose, and the usage and dosage were the same as the topical compound tripterygium group.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACR20 criteria | Week 4 | To meet the criteria, a patient must have 20% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 20% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the Health Assessment Questionnaire (HAQ), and the ESR or serum C-reactive protein (CRP) level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACR50 criteria | Week 4 | To meet the criteria, a patient must have 50% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 50% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the Health Assessment Questionnaire (HAQ), and the ESR or serum C-reactive protein (CRP) level. |
| 28-joint count Disease Activity Score (DAS28) | Baselin and week 4 | — |
Outcome results
None listed