Health Condition 1: M859- Disorder of bone density and structure, unspecified
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: i. Women between 50 and 70 years with history of spontaneous amenorrhea for equal or more than 12 months. ii. B.M.D. T score between -1.0 and -2.5 measured by DXA Scan of neck of femur or lumbar spine.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of congenital disorders related to bone like Dysosteogenesis, Marfans Syndrome, Osteomalacia and Pagets disease. 2. Patients with a history of Endocrinal disorders like Thyroid and parathyroid dysfunction, Hyperprolactinemia and Cushings syndrome. 3. Patients with history of Malabsorption syndrome. 4. Patients who have undergone Organ transplantation, who are immobilized for more than 6 weeks, traumatic bone fractures in last 6 months. 5. Patients with a history of any Malignancy. 6. Known cases of uncontrolled diabetes mellitus with HbA1c more than 8 percent, uncontrolled hypertension with BP equal or more than 160 per 100 mm Hg, Renal dysfunction defined as Serum creatinine more than 1.2 mg per dl, Hepatic dysfunction defined as AST and ALT more than 2 times of the normal upper limit, cardiac dysfunction, urolithiasisis and any other condition that may jeopardize the study. 7. Patients on calcium and Vitamin D supplementation or any osteopenia treatment or hormone replacement therapy. 8. Patients who are participating in any clinical trial currently or have completed participation in any other clinical trial during the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in bone mineral densityTimepoint: At Baseline, 90th day( for every 10th patient) and 180th day assessed by DXA scan. | — |
Secondary
| Measure | Time frame |
|---|---|
| i.Change in hematological & biochemical parameters (Liver function test & renal function tests) ii. Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events during the study period. iii. Assessment of treatment adherence through self-reported compliance log & counting of used medication containers/strips. Timepoint: i.90th day & 180th day as compared to baseline ii. Day 30, 60, 90,120,150,180 iii. Day 1 to Day 180 | — |
Countries
India
Contacts
Public ContactDr Renu Rani
Central Ayurveda Research Institute under CCRAS
Outcome results
None listed