Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis

Study Overview
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Brief Summary
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To study the efficacy of TCM as an effective supplement in addition to the traditional treatment in RA.

Detailed Description
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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.

Official Title
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Lingzhi (Ganoderma Lucidum) and Sen Miao San Supplementation in Rheumatoid Arthritis(RA): An Animal Model and A Phase I Study

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Lingzhi and Sen Miao San


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo with Lingzhi(Granoderma Lucidum) and Sen Miao San | Drug: Lingzhi and Sen Miao San<br>* 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.<br>* Other names: Niuxi Achyranthes bidentata B1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | wk52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | wk52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lingzhi, Sen Miao San, Rheumatoid Arthritis