Health Condition 1: null- RHEUMATOID ARTHRITIS VIS â??Aâ??VIS AMAVATA
Conditions
Interventions
Intervention1: INDUKANTA GHRITA
TRAYODASHANG GUGGULU: 1. Indukanta Ghrita (API Part II, Vol-II Pg. no. 96-99)
Dose : 10 gm BD (30 minutes before meal)
Dosage form : Ghrita
Anupan : W
Sponsors
CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 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 r adiograph that must include erosions or unequivocal bony decalcification, localized in or adjacent to involved joints. 3) Adult onset 4 ) Duration of establish diseases > 2 years. 5) 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 diseases, 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 (140/90 mmHg) 5. Patients suffering with uncontrolled Diabetes mellitus (HBA1c > 6.5%) 6. Patients diagnosed with other arthritis like gouty arthritis, tuberculosis 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 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 disorders (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 more than upper limit of normal >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, 15th day, 29th day, 43rd day, 57th day, and 71th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Disability Index (The Indian Health Assessment Questionnaire) Change in acute phase reactants â?? ESR and CRP Change in Health Questionnaire SF-36 Patientâ??s global assessment of diseases activity. Physicianâ??s global assessment of diseases activity Pain VAS scale ( Visual Analogue Scale) (0-100) Any adverse drug reaction or adverse event Timepoint: At Baseline, 15th day, 29th day, 43rd day, 57th day, and 71th day. | — |
Countries
India
Contacts
Public ContactDr Krishna RaoS
NATIONAL AYURVEDA RESEARCH INSTITUTE FOR PANCHAKARMA
Outcome results
None listed