Rheumatoid Arthritis Musculoskeletal Diseases Rheumatoid arthritis (RA)
Conditions
Interventions
Arm 1: Consultation + individualised homeopathic treatment
Arm 2: Consultation + rheumatoid complex
Arm 3: Consultation + placebo
Arm 4: No consultation + rheumatoid complex
Arm 5: No consultation + p
Sponsors
University of Southampton (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged over 18 2. Formal diagnosis of RA (American College of Rheumatology [ACR] guidelines) for at least two years 3. On stable medication for at least three months 4. Have a minimum Disease Activity Score (DAS) of over 2.6 (based on Fuch?s 28 joint count) 5. Have a Patient Global Assessment (visual analogue scale [VAS]) score of 30 mm or above and at least 3 tender joints 6. Ability to comply with the requirements of the study and to give informed consent
Exclusion criteria
Exclusion criteria: 1. Those with severe co-morbidities e.g. cancer that would make their RA symptoms unstable 2. Participation in an investigational trial within 45 days prior to enrolment 3. Those patients having any condition that requires immunosuppressant treatments for the treatment of cancer 4. Those patients taking biological disease-modifying anti-rheumatic drugs (i.e. anti-tumour necrosis factor [TNF]) 5. Those classified as functional status IV based on the Classification of Global Functional Status in Rheumatoid Arthritis 6. Those who are currently using homeopathy, or have used homeopathy within the past 3 months 7. Those who are pregnant or hoping to become pregnant or breastfeed within the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 20% improvement from baseline to end of treatment in global RA symptoms (ACR20, a binary outcome) based on the Outcome Measures for Arthritis Clinical Trials (OMERACT) 2. 35% improvement in patient global assessment scores from baseline to the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 15% improvement from baseline to end of treatment in the Measure Yourself Medical Outcome Profile scores (MYMOP, a continuous variable) 2. Time to flare 3. Four weekly Disease Activity Score 4. Weekly analgesic use, and changes in conventional medication 5. Weekly pain scores 6. Weekly global assessment of symptoms 7. Adverse event monitoring | — |
Countries
United Kingdom
Outcome results
None listed