Health Condition 1: null- osteopenia
Conditions
Interventions
Intervention1: Tablet Zanosto: Zanosto tablets (ingredients are Mukta Shukti Bhasma (Calx of Oysters), Asthi Shrinkhala (Cissus quadrangularis), Ashwagandha (Withania somnifera) & Methi (Trigonella fo
Sponsors
Emami Limited Kolkata
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 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 consuming any drug 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 is either 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 treatment for osteopenia other than vitamin supplements. 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 |
|---|---|
| Change in BMD score between the 2 study groups at the end of treatment.Timepoint: day 0 and day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the Quality of Life score between the 2 study groups at the end of treatmentTimepoint: 0 days, 90 days, 180 days;Any significant change in the study related laboratory safety parametersTimepoint: 0 days, 90 days, 180 Days;Change in the levels of the biochemical markers (Sr. Calcium, vitamin D3, Osteocalcin & bone specific alkaline phosphatase levels) between 2 study groups at the end of treatment Timepoint: 0 day, 90 days, 180 days | — |
Countries
India
Contacts
Public ContactDr Renuka Munshi
TNMC @ BYL Nair Ch. Hospital
Outcome results
None listed