Health Condition 1: null- patients of Rheumatoid arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both genders between 18 and 60 years of age. 2. Newly onset Rheumatoid arthritis patients having disease duration less than 1 year with diagnosis of RA according to the 2010 ACR/EULAR criteria. 3. Rheumatoid arthritis patients partially responding to methotrexate therapy. Details All patients with rheumatoid arthritis (RA) attending the OP or IP services of the Department of Immunology after thorough clinical and laboratory investigations, they will receive methotrexate (unless contraindicated) as initial DMARD (Disease-Modifying Antirheumatic Drugs ) therapy 10 mg per week, escalated @ 5 mg / week, every 2 weeks up to a maximum of 25 mg per week or maximum tolerated dose whichever is less at the end of 6 weeks. Patients will receive NSAlDs (Diclofenac 50 mg twice a day and SOS basis for control of pain). Treatment response will be assessed using EULAR response criteria at the end of three months or after 6 continuous weeks of stable combination DMARD therapy whichever is later. Based on the treatment response patients will be classified as â??good, moderate and poor responderâ??. Patients with complete response to methotrexate will continue the same medication. Whereas, those with poor response will be offered additional DMARD therapy (triple therapy). These two groups will not be recruited in the study. The patients labeled as â??partial respondersâ?? will be continued on methotrexate for a further period of 3 months. They will be enrolled in the study during this phase of stable methotrexate therapy.
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus 2. Uncontrolled Hypertension (JNC 7 report) 3. Rheumatoid arthritis patients with apparent deformities. 4. Any other neuromuscular disorder. 5. Any other Auto immune disorders. 6. Patients who have undergone yoga therapy or any other bio-feedback techniques in last one year. 7. History of alcoholism or drug abuse within 1 year of screening. 8. Intra-articular steroid injections with in 4 weeks of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Disease activity scale-28 2.Biochemical & Immunological parameters i) Inflammatory markers 1) ESR 2) IL-6 3) IL-1 4) TNF-α ii) Oxidative stress markers 1) Serum malondialdehyde 2) Total antioxidant status iii) adipokines â?? adiponectin,leptin iv) serum cortisol (8.00 AM) 3. Cardiac autonomic function assessed by short term Heart Rate Variability. 4. BRS(Baroreflex sensitivity) Timepoint: baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life by Health Assessment QuestionnaireTimepoint: baseline and 12 weeks | — |
Countries
India
Contacts
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER