Health Condition 1: null- Rheumatoid arthritis patients having at least 4 out of 7 criteria American Rhumatology association
Conditions
Interventions
Intervention1: 1.VATARI GUGGULU
2.HINGVASTAKA CHURNA
3.BRIHAT SAINDHABADYA TAILA: 1.VATARI GUGGULU-1 GRAM ORALLY THRICE DAILY FOR 12 WEEKS 2.HINGVASTAKA CHURNA-3 GRAMS ORALLY TWICE DAILY FOR 12 WEEK
Sponsors
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES
Eligibility
Inclusion criteria
Inclusion criteria: 2. 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 week 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 week duration). c) Arthritis of hand joints, at least 1 area in wrist and hand is swollen (more than 6 week duration). d) Symmetric arthritis (more than 6 week 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. 3. Patients willing to give written informed consent to participate in the study for 16 weeks including 4 weeks without drug follow-up
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 of juvenile rheumatoid Arthritis diagnosed before the age of 16 years. 3. Patients who are unable to walk without support and / or confined to wheel chair. 4. Patients suffering with Diabetes Mellitus (HbA1c > 6.5). 5. Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis etc. 6. 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. 7. Patients who have a known history of Cardiovascular diseases. 8. 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 >1.4mg/dL), Pulmonary Dysfunction (Uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), 9. Alcoholics and/or drug abusers. 10. H/o hypersensitivity to any of the trial drugs or their ingredients. 11. Pregnant / lactating woman. 12. Patients who have completed participation in any other clinical trial during the past six months. 13. Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measure â?¢ Changes in DAS-28 score Timepoint: DAY 1,EVERY 14 DAYS UPTO 84 DAYS AND ON 112TH DAY | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change in Disability Index (The Indian Health Assessment Questionnaire) â?¢ Change in acute phase reactants â?? ESR and CRP â?¢ Change in Health Questionnaire SF-36 Timepoint: Total Study Period 12 months Washout / Preparatory Period (if required) 1 month Recruitment 6 months Treatment Period 12 weeks Follow-Up Period 4 weeks Statistical Analysis 1 month | — |
Countries
India
Contacts
Public ContactDr DIPSUNDAR SAHU
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES, JANAKPURI, NEW DELHI
Outcome results
None listed