Clinical trial NCT00432484: Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis
Official title: Lingzhi (Ganoderma Lucidum) and Sen Miao San Supplementation in Rheumatoid Arthritis(RA): An Animal Model and A Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Lingzhi
Sen Miao San
Rheumatoid Arthritis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2007-02-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 San)or placebo.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: We assessed the proportion of patients showing a clinical response of at least 20% and 50% as defined by the American College of Rheumatology (ACR) criteria (20).
timeFrame: wk52
Secondary outcomes:
measure: The change in the number of swollen and tender joint counts, and the levels of ESR, CRP, the inflammatory markers, cytokine levels and oxidative stress will be assessed as secondary outcomes.
timeFrame: wk52
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Institute of Chinese Medicine
Study officials:
affiliation: Chinese University of Hong Kong
name: Edmund K Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.