Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT00432484|
Recruitment Status : Completed
First Posted : February 7, 2007
Last Update Posted : May 9, 2008
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Lingzhi and Sen Miao San||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Lingzhi (Ganoderma Lucidum) and Sen Miao San Supplementation in Rheumatoid Arthritis(RA): An Animal Model and A Phase I Study|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
Placebo Comparator: 1
Placebo with Lingzhi(Granoderma Lucidum) and Sen Miao San
Drug: 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.
- 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). [ Time Frame: wk52 ]
- 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. [ Time Frame: wk52 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432484
|The Institute of Chinese Medicine|
|Hong Kong, China|
|Principal Investigator:||Edmund K Li, MD||Chinese University of Hong Kong|