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To study the efficacy of TCM as an effective supplement in addition to the traditional treatment in RA.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo with Lingzhi(Granoderma Lucidum) and Sen Miao San |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lingzhi and Sen Miao San | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edmund K Li, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Institute of Chinese Medicine | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17907228 | Derived | 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. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |