Health Condition 1: null- Patients of either sex with in the age group of 40-65 years of agecomplaining of Bone pain and decaying BMD score between -1 to -3 on DEXA scan selected for trial perticipent.
Conditions
Interventions
Intervention1: ABHADYA CHURNA AND MUKTA SUKTI BHASMA: Abhadya Churna (AFI -Part III-Vol.- I Pg.123-124).
Dose 5 gm (1 Sachet of 5gm) twice daily
Sponsors
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients of either sex between 40 to 65 years of age. 2 B.M.D -T. Score between ( -1 to -3 ) on DEXA Scan. 3 Willing and able to participate for 14 weeks.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Patients who are consuming corticosteroids (more than 5mg/day of prednisolone or equivalent) for more than 3 months 2. Patients with history of Fragility Fracture. 3. Patients suffering from congenital disorders related to bone (Dysosteogenesis, Marfanâ??s Syndrome, etc.) 4. Patients with (Hypothyroidism and Hyperthyroidism, Hypoparathyroidism and Hyperparathyroidism, Cushingâ??s syndrome) 5. Patients with unstable CV diseases 6. Patients suffering from Osteomalacia. 7. Patients suffering from Malabsorption syndrome 8. Patients who have undergone Organ transplantation 9. Patients who are immobilized since > 6 weeks 10. Patients with history of bone fracture in last 6 months. 11. Patients with concurrent serious cardiac, 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 Diabetes Mellitus 13. Alcoholics and/or drug abusers. 14. Patients with evidence of malignancy 15. Patients suffering from major systemic illness necessitating long term drug treatment/Auto-Immune disorders (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 16. Pregnant or lactating woman. 17. H/o hypersensitivity to any of the trial drugs or their ingredients 18. Patients who have completed participation in any other clinical trial during the past Six (06) months. 19. Patients on calcium and Vitamin D supplementation. 20. Patients with history of Urolithiasis. 21. Known cases of Pagetâ??s disease of bone 22. Any other condition which the investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Serum â?? Osteocalcin level from Baseline to end of study Timepoint: With in 12 weeks of study period we can observe the change of BMD tscore,Change in Bone specific alkaline Phosphatase and change in Quality of life index. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change in Quality of Life index (QUALEFFO-41) â?¢ Change in Bone Specific Alkaline Phosphatase Timepoint: Total Study Period 24 months Washout (if required) 2 weeks Recruitment 14 months Treatment Period 12 weeks Follow-Up Period 2 weeks Statistical Analysis 3 months | — |
Countries
India
Contacts
Public ContactDrDipSundar Sahu
National Research Institute of Ayurvedic Drugs Development
Outcome results
None listed