Health Condition 1: null- Osteopenia/Osteoporosis
Conditions
Interventions
Intervention1: Laksha Guggulu: Dose â?? 1gm (2 Tablets) twice daily
Dosage form - Tablet of 500 mg
Route of Administration â?? oral
Time of Administration-Twice a day after food
Anupana-Lukewarm Wat
Sponsors
Department of AYUSH Ministry of Health Family Welfare Government of India
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients of either sex between 45 to 65 years of age. 2 B.M.D.T-. Score of 3 Willing and able to participate for 16 weeks
Exclusion criteria
Exclusion criteria: 1. Patients who are consuming any drug which is known to affect bone metabolism for e.g. SERMs, bisphophonates, 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 with history of Fragility Fracture. 3. Patients suffering from congenital disorders (Dysosteogenesis and Marfanâ??s Syndrome) 4. Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushingâ??s syndrome) 5. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg) 6. Patients suffering from Osteomalacia. 7. Patients whose Serum Ca++ level 2.6 mmol/L ( 10.5 mg/dL) 8. Patients suffering from Malabsorption syndrome 9. Patients who have undergone Organ transplantation 10. Patients who are immobilized since > 6 weeks 11. Patients with history of Long bone fracture in last 6 months. 12. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 13. Symptomatic patient with clinical evidence of Heart failure. 14. 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. 15. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%) 16. Alcoholics and/or drug abusers. 17. Patients with evidence of malignancy 18. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 19. Pregnant or lactating woman. 20. H/o hypersensitivity to any of the trial drugs or their ingredients 21. Patients who have completed participation in any other clinical trial during the past six (06) months. 22. Any other condition which the P.I. thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Change in Quality of Life index (QUALEFFO-41)Timepoint: At Baseline, at 84th day and at the end of follow up after 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change in Bone Mineral Density (T-score)Timepoint: At Baseline and at the 84th day. | — |
Countries
India
Contacts
Public ContactDr Pradeep Dua
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed