Rheumatoid Arthritis
Conditions
Keywords
Lingzhi, Sen Miao San, Rheumatoid Arthritis
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.
Interventions
DRUGLingzhi 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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
China
Outcome results
None listed