Rheumatoid Arthritis
Conditions
Interventions
A:Tu Fu Ling Tablets, 200mg Bid. Other: Placebo
B:Tu Fu Ling Tablets, 100mg Tid. Other: Placebo.
C:Leflunomide Tablets, 20mg Qd. Other: Placebo
Sponsors
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: The participants diagnosed with RA in accord with the American College of Rheumatology (ACR) 1987 revised criteria were enrolled. All participants had to have an ACR functional class of I, II, or III, and be in the radiographic Staging of I, II, or III. Disease-modifying antirheumatic drugs (DMARDs) and immunosuppressants were discontinued at least 30 days before the initial administration. Participants receiving a stable dosing regimen of the same glucocorticoids e.g. prednisolone (10 mg daily maximum) prior to entering the study were allowed. In addition, written informed consent was obtained from each participants before enrollment.
Exclusion criteria
Exclusion criteria: Pregnant women, nursing women, and women of child bearing potential not using an effective method of contraception were excluded. Participants were also excluded if they had severe disability, a history of a serious allergic reaction, any other concurrent rheumatic disease such as systemic lupus erythematosus, sjogren's syndrome, severe osteoarthritis, or significant cardiac, blood, respiratory, neurological, endocrine, renal, hepatic, gastrointestinal, or psychotic disease, or an active intercurrent infection. Participants in another clinical study within 4 months of study entrywere excluded as well. Moreover, the participants suspected of having a history of alcohol or drug abuse, and in any condition or situation that may interfere with the participation were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| American College of Rheumatology (ACR20) core criteria;Adverse events rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| RA related symptoms: Number of tender and swollen joints assessed using 28-joint counts, pain assess;Safety factor; | — |
Countries
China
Contacts
Public ContactWei Liu
Tianjin University of Traditional Chinese Medicine
Outcome results
None listed