Health Condition 1: M150- Primary generalized (osteo)arthritis
Conditions
Interventions
Intervention1: Vijaya Oil: Local Application-Twice a day.
Control Intervention1: Not applicable: NIL
Sponsors
Bombay Hemp Company
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either sex between the age group of 30-75 years (both years inclusive) 2. Patients suffering from Sandhigata Vata (Osteoarthrosis) . 3. Those with a history of fractures that may have occurred with a minor injury or fall. 4. Ready to abide by trial procedures and to give informed consent.
Exclusion criteria
Exclusion criteria: 1.Patient suffering from Osteomalacia, Tumor, Osteonecrosis, infection, and other bone-softening metabolic disorders. 2. Patients suffering from congenital disorders (Dysosteogenesis and Marfanâ??s Syndrome) 3. Patients with Leukemia, Lymphoma, Metastases (bony and other), Pathologic fractures secondary to bone metastases from cancer, Pediatric osteogenesis imperfect or Renal osteodystrophy, Malabsorption syndrome. 4. Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushingâ??s syndrome) 5. Patients who have undergone Organ transplantation 6. Patients who are immobilized since > 6 weeks 7. Any other serious illness e.g. Hepatic/renal failure. 8. Patient receiving any other treatment for osteopenia other than vitamin supplements. 9. Patients requiring long term treatment of oral and/or injectable steroids or surgical intervention. 10. Symptomatic patient with clinical evidence of Heart failure. 11. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. 12. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%) 13. Alcoholics and/or drug abusers. 14. Pregnant and lactating women, 15. H/o hypersensitivity to any of the trial drugs or their ingredients 16. Patients who have completed participation in any other clinical trial during the past six (06) months. 17. Any other condition which the P.I. thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC), Visual Analog Scale (VAS) for pain assessment in study group before and after intervention i.e b/w day 0 and day 60.Timepoint: To assess the change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC), Visual Analog Scale (VAS) for pain assessment in study group before and after intervention i.e b/w day 0 and day 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| a)To assess the safety of Vijaya Oil in Osteoarthrosis before and after intervention,i.e, between day 0 and day 60. b) To assess the change in the Quality of Life score in the study group before and after intervention,i.e, between day 0 and day 60.Timepoint: a)To assess the safety of Vijaya Oil in Osteoarthrosis before and after intervention,i.e, between day 0 and day 60. b) To assess the change in the Quality of Life score in the study group before and after intervention,i.e, between day 0 and day 60. | — |
Countries
India
Contacts
Public ContactShehla Akhlak
National Institute Of Ayurveda, Jaipur.
Outcome results
None listed