Health Condition 1: null- Osteopenia/Osteoporosis (BMD T score between -1 to -3)
Conditions
Interventions
Intervention1: Ashwagandha Churna
(API Part-I
Vol.-I).
: Dose- 3gm twice daily
Dosage form- Powder
Route of Administration-Oral
Time of Administration- Twice a day after food
Anupana- Lukewarm Water
Duration of therapy-12 weeks
Intervention2: Pr
Sponsors
Central Council for Research in Ayurvedic Sciences CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 1. B.M.D -T. Score between ( -1 to -3 ) on DEXA Scan. 2. Willing and able to participate for 14 weeks
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 MellitusBlood sugar (fasting >126 and PP >200mg/dl) 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 - Osteocalcin level from Baseline to end of studyTimepoint: At Baseline and and 84th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Bone Specific Alkaline PhosphataseTimepoint: At Baseline and and 84th day;Change in Quality of Life index (QUALEFFO-41)Timepoint: At Baseline, at the end of 12 weeks and end of 14 weeks | — |
Countries
India
Contacts
Public ContactDr Manohar S Gundeti
R.R.A. Podar Ayurveda Cancer Research Institute (CCRAS)
Outcome results
None listed