Health Condition 1: null- Rheumatoid Arthritis (Amavata)
Conditions
Interventions
Intervention1: 1. Vatari Guggulu
2. Rasna saptaka Kashaya: Group â?? I
1. Vatari Guggulu
Dose 1.5 gm (3 tablets of 500mg each) BD
Dosage form Tablet
Route of Administration Oral
Time of A
Sponsors
CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 1). Patients of either sex with age between 20 and 60 years 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 12 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 mmHg) 5. Patients suffering with Diabetes Mellitus {Blood Sugar Fasting > 126 mg/dl). 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 months. 15. Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in DAS-28 score- Timepoint: At Baseline,14th day,28th day,42nd day,56th day,70th day and 84th day | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in Disability Index (The Indian Health Assessment Questionnaire)-Timepoint: At Baseline,14th day,28th day,42nd day,56th day,70th day and 84th day;Change in acute phase reactants ( ESR and CRP )Timepoint: At Baseline,14th day,28th day,42nd day,56th day,70th day and 84th day;Change in Health Questionnaire SF-36Timepoint: At Baseline and 84th day | — |
Countries
India
Contacts
Public ContactDr Sunita
CCRAS
Outcome results
None listed