Complementary Herbal Approach to Rheumatoid Management Study (CHARMS)
ConditionRheumatoid Arthritis (RA)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age21-70
SponsorSingapore General Hospital
About this trial
Rheumatoid Arthritis (RA) is a chronic disease characterised by symmetric, polyarticular pain and swelling, involving small joints of the hands and feet. RA can lead to irreversible joint damage without treatment, causing disability and impacting daily activities and work productivity. Some patients turn to Chinese Herbal Medication (CHM) for treatment. Since there is currently no well designed randomised controlled trial to support the 'real-world' use of Si Miao Xiao Bi Tang with anti-rheumatic drugs, such as methotrexate, the investigators are conducting a 12-week, randomised double-blinded placebo-controlled trial to determine the efficacy, safety and cost effectiveness of a modified Si Miao Xiao Bi Tang, a type of CHM, in the treatment of patients with active RA.
Eligibility criteria
Qualifiers
Patients between the ages of 21 and 70 years, and diagnosed with RA by a rheumatologist and fulfilling the 2010 ACR/EULAR classification criteria for RA.
Active disease with DAS28 ESR ≥3.2 at screening, with at least 6 swollen joints out of 66 and at least 6 tender joints out of 68.
Receiving stable doses of methotrexate therapy for at least 3 months, and on stable dose for at least 4 weeks before trial entry ( ≥10mg per week), either subcutaneous or orally.
Stable doses of non-steroidal anti-inflammatory drugs (NSAIDS), acetaminophen, or oral corticosteroids (equivalent to prednisone ≤ 10 mg) for at least 4 weeks prior to first dose of study medication.
Disqualifiers
Not able to provide informed consent.
Previous lack of efficacy to Si Miao Xiao Bi Tang.
History of inflammatory joint disease other than RA. Secondary Sjogren's Syndrome is permitted.
Concurrent use of other immunosuppressant medications, except MTX and protocol allowed doses of steroids.
Trial design
Treatments tested in this trial
- Shu Bi Ning (modified Si Miao Xiao Bi)
- Methotrexate
- Shu Bi Ning placebo
Treatment groups
132 Participants
are divided into 2 treatment groupsLocations
1Singapore General Hospital169608, Singapore Singapore
Sponsors and collaborators
Singapore General Hospital
Lead sponsor
Thong Chai Institute of Medical Research
Collaborator
Source ClinicalTrials.gov