Status:
COMPLETED
Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To study the efficacy of TCM as an effective supplement in addition to the traditional treatment in RA.
Detailed Description
It is a prospective, double-blind, randomized, placebo-controlled study in patients with RA. It consists of a 24 - weeks period of randomized double-blind treatment of either TCM(Lingzhi and Sen Miao ...
Eligibility Criteria
Inclusion
- Fulfilled the 1987 American College of Rheumatology (ACR) criteria for RA.
- The presence of 2 or more swollen or tender joints, based on 28-joint count.
- Morning stiffness lasting for 30 minutes.
- Erythrocyte sedimentation rate (ESR) of 28 mm/hour, despite treatment with disease modifying agent including MTX, sulphasalazine, hydroxychloroquine, auranofin or azathioprine were recruited into the study.
- Patients taking glucocorticoids (prednisone \< 7.5 mg/day) and/or nonsteroidal antiinflammatory drugs must have been taking a stable dosage for at least 4 weeks before entering the trial and were required to take the same dosage throughout the trial.
- Patients had radiographic erosive diseases.
Exclusion
- Patients who are pregnant or nursing mothers.
- Severe liver disease (e.g cirrhosis, chronic active hepatitis)
- Renal impairment (serum creatinine level \> 150mmol/L)
- Known hypersensitivity to herbal medicine
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00432484
Start Date
May 1 2005
End Date
December 1 2006
Last Update
May 9 2008
Active Locations (1)
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1
The Institute of Chinese Medicine
Hong Kong, China