Health Condition 1: null- RHEUMATOID ARTHRITIS
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed RA according to American College of Rheumatology 1987 classification criteria and the new ACR/EULAR 2010 criteria 2.RA disease duration >=6 months 3.Pain VAS >= 4 cm (10 cm scale) 4.Requiring frequent pain relieving medication for over 2 weeks or moderately severe pain interfering with daily activities of at least 2 weeks duration 5.Patient receiving supervised standard of care treatment for RA for at least 12 weeks. 6.Able to understand the study and willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1.Oral steroid equivalent prednisolone >10 mg daily and unstable consumption of 4 weeks prior to screening. 2.Male or female patients 75 years of age 3.Patients with abnormal kidney function test as per standard laboratory criteria. 4.Serum K+ levelË?5.5 mEq/L 5.Patients with Uncontrolled diabetes and hypertension 6.Patients on diuretics or any drug altering serum K+ 7.Pregnant or breast feeding women 8.Patients who are incapacitated largely or wholly bedridden. 9.Patients on any herbal, homeopathic or ayurvedic medicine. 10Patients with history of heart failure or unstable angina. 11. History or presence of any medical or psychiatric condition. 12.Any other concern as per discretion of rheumatologist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in maximum pain experienced during last 24 hours measured on Visual Analogue ScaleTimepoint: Baseline and follow up end points at monthly interval up to study completion at 16 weeks (0,1 month, 2 months, 3 months and completion) | — |
Secondary
| Measure | Time frame |
|---|---|
| Joint Counts for pain/ swelling, Physician and patients global assessment, Health assessment questionnaire RA pain score, SF36(Physical and mental), ESR,CRP titer,DAS 28 (Disease Activity Score/EULAR), ACR index improvement(@0%,50%,70%)Timepoint: Baseline and follow up end points at monthly interval up to study completion at 16 weeks (0,1 month, 2 months, 3 months and completion) | — |
Countries
India
Contacts
CENTER FOR RHEUMATIC DISEASES