Health Condition 1: - Health Condition 2: M859- Disorder of bone density and structure, unspecified Health Condition 3: M859- Disorder of bone density and structure, unspecified
Conditions
Interventions
Intervention1: Asthiposhak Vati: 2 Tablet TDS orally With Lukewarm Water
Total Duration of Therapy 30 days
Control Intervention1: Not applicable: Not applicable
Sponsors
Shri Dhootapapeshwar Limited Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex between the age group of 40-75 years (both years inclusive) 2. Patients suffering from ASTHIKSHAYA (Osteopenia) with BMD T- score between (-1 to -2.5) 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. Patients who are consuming any drug which is known to affect bone metabolism for e.g. SERMs, bisphosphonates, calcitonin, Vit.D (more than 60,000 units) and corticosteroids (more than 5mg/day of prednisolone or equivalent) for more than 3 months, methotrexate, anti- convulsants, diuretics, etc. 2. Patients whose Serum Ca++ level 2.6 mmol/L ( 10.5 mg/dL) 3. Patient suffering from Osteomalacia, Tumor, Osteonecrosis, Infection, and other bone-softening metabolic disorders. 4. Patients suffering from congenital disorders (Dysosteogenesis and Marfanâ??s Syndrome) 5. Patients with Leukemia, Lymphoma, Metastases (bony and other), Pathologic fractures secondary to bone metastases from cancer, Pediatric osteogenesis imperfect or Renal osteodystrophy, Malabsorption syndrome 6. Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushingâ??s syndrome) 7. Patients who have undergone Organ transplantation 8. Patients who are immobilized since > 6 weeks 9. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 10. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg) 11. Any other serious illness e.g. Hepatic/renal failure. 12. Patient receiving any other method of treatment. 13. Patients requiring long term treatment of oral and/or injectable steroids or surgical intervention. 14. Symptomatic patient with clinical evidence of Heart failure. 15. 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. 16. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%) 17. Alcoholics and/or drug abusers. 18. Pregnant and lactating women, 19. H/o hypersensitivity to any of the trial drugs or their ingredients 20. Patients who have completed participation in any other clinical trial during the past six (06) months. 21. Any other condition which the P.I. thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a)To assess the change in the BMD score after intervention.Timepoint: a)To assess the change in the BMD score after intervention at 8th visit (180 dqys) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the change in the Ayurvedic symptom after intervention.Timepoint: To evaluate the change in the Ayurvedic symptom score after intervention at 8th visit (180 days) | — |
Countries
India
Contacts
Public ContactKhushal Kumar
National Institute Of Ayurveda Jaipur
Outcome results
None listed