Health Condition 1: null- Rheumatoid Arthritis
Conditions
Interventions
Intervention1: Simhanaada Guggulu along with Brihat Saindhavadi Taila: ORALLY SIMHANAADA GUGGULU Dose â?? 1.5 gm (3 Tablets) twice daily
Duration of therapy-12 weeks AND LOCALLY - BRIHATA SAINDHAVADI TAILA Dose â?? 20 ml twice daily
Duration of therapy-12 weeks
Intervention2: Brihata Saindhavadi Taila: Dose â?? 20 ml twice daily
Dosage form â?? Oil
Route of Administration â?? Local Application
Time of Administration-Twice a day
Sponsors
Central Council for Research in Ayurvedic Sciences CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Presence of any four out of the following seven criteria (according to 1987, revised criteria of American College of Rheumatology) a. Morning stiffness: Stiffness in and around joints lasting one hour before maximal improvement (More than 6 weekâ??s duration). b. Arthritis of three or more joints, at least three joint area, observed by Physician, having pain with soft tissue swelling or joint effusion, not just bony over growth, (more than 6 weeks duration). c. Arthritis of hand joints, at least 1 area in wrist and hand is swollen (more than 6 weeks duration). d. Symmetric arthritis (more than 6 weekâ??s duration). e. Presence of rheumatoid Nodules f. Serum rheumatoid factor- positive g. Typical radiographic changes of arthritis on PA view of hand & wrist radiograph that must include erosions or unequivocal bony decalcification, localized in or adjacent to involved joints. 2. Patients Willing and able to participate in the study for 16 weeks.
Exclusion criteria
Exclusion criteria: 1. Patients who have developed complications of Rheumatoid Arthritis e.g. deformity of joints / bones, pleura-pericardial disease, or else. 2. Patients who are unable to walk without support and / or confined to wheel chair. 3. Patients with structural deformity as the complication of RA. 4. Patients with poorly controlled Hypertension ( >160/100 mm of Hg) 5. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP) >200 mg% OR HbA1c > 6.5%} 6. Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis etc. 7. Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 9. Symptomatic patients with clinical evidence of Heart failure. 10. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study. 11. Alcoholics and/or drug abusers. 12. H/o hypersensitivity to any of the trial drugs or their ingredients. 13. Pregnant / lactating woman. 14. Patients who have completed participation in any other clinical trial during the past six (06) months. 15. Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in DAS-28 scoreTimepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 14th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in acute phase reactants â?? ESR and CRPTimepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 14th week.;Change in Disability Index (The Indian Health Assessment Questionnaire)Timepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 14th week.;Change in Health Questionnaire SF-36Timepoint: SF-36 is assessed at Baseline, 84th day and at the end of follow up after 14 weeks. | — |
Countries
India
Contacts
Public ContactDr Pradeep Dua
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed