Rheumatoid Arthritis Clinical Trial
Official title:
Lingzhi (Ganoderma Lucidum) and Sen Miao San Supplementation in Rheumatoid Arthritis(RA): An Animal Model and A Phase I Study
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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