Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis
NCT ID: NCT00432484
Last Updated: 2008-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2005-05-31
2006-12-31
Brief Summary
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Detailed Description
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Primary outcome is assessed by showing a clinical response of at least 20% and 50% as defined by the American College of Rheumatology (ACR) criteria.Secondary outcome is defined as the changes in the number of swollen and tender joint counts, and the levels of ESR, CRP, the inflammatory markers, cytokine levels and oxidative stress.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Placebo with Lingzhi(Granoderma Lucidum) and Sen Miao San
Lingzhi and Sen Miao San
G lucidum and SMS were supplied as capsules, containing 4.0 gm of G lucidum extract, 2.4 gm of Rhizoma atractylodis (Cangzhu), 2.4 gm of Cotex phellodendri(Huangbai), and 2.4 gm of Radix achyranthes Bidentatae(Niuxi). Each patient took either 3 capsules twice daily as recommended by the TCM experts or identical-looking placebo.
Interventions
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Lingzhi and Sen Miao San
G lucidum and SMS were supplied as capsules, containing 4.0 gm of G lucidum extract, 2.4 gm of Rhizoma atractylodis (Cangzhu), 2.4 gm of Cotex phellodendri(Huangbai), and 2.4 gm of Radix achyranthes Bidentatae(Niuxi). Each patient took either 3 capsules twice daily as recommended by the TCM experts or identical-looking placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Severe liver disease (e.g cirrhosis, chronic active hepatitis)
* Renal impairment (serum creatinine level \> 150mmol/L)
* Known hypersensitivity to herbal medicine
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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The Chinese University of Hong Kong
Principal Investigators
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Edmund K Li, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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The Institute of Chinese Medicine
Hong Kong, , China
Countries
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References
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Li EK, Tam LS, Wong CK, Li WC, Lam CW, Wachtel-Galor S, Benzie IF, Bao YX, Leung PC, Tomlinson B. Safety and efficacy of Ganoderma lucidum (lingzhi) and San Miao San supplementation in patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled pilot trial. Arthritis Rheum. 2007 Oct 15;57(7):1143-50. doi: 10.1002/art.22994.
Other Identifiers
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RA-2005-001
Identifier Type: -
Identifier Source: org_study_id