Clinical trial for safety and efficacy of grassroots leads in the management of Osteopenia / Osteoporosis among postmenopausal women.
- Conditions
- Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
- Registration Number
- CTRI/2019/06/019792
- Lead Sponsor
- ational innovation foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Postmenopausal women, defined as no menstruation for the last 12 months.
2. B.M.D.T. Score -1 to -3.5 at hip, spine and forearm (worst score at any of
the three sites to be considered)
1. B.M.D. T. score above -1 and less than -3.5
2. All women who are consuming any drug which is known to affect bone metabolism in doses for e.g. SERMs, bisphophonates, calcitonin, Vit. D more than 60,000 units and corticosteroids more than 5mg/day for more than 3 months, methotrexate, anticonvulsants and diuretics.
3. Patients suffering from congenital disorders (Dysosteogenesis and Marfan.s Syndrome)
4. Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushing.s syndrome)
5. Patients with evidence of malignancy
6. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Epilepsy)
7. Patients suffering from chronic hepatic disorder, renal failure or cardiac dysfunction.
8. Patient suffering from uncontrolled DM-2 or uncontrolled hypertension.
8. Patients suffering from Osteomalacia.
9. Patients suffering from Malabsorption syndrome
10. Patients undergone Organ transplantation or on immunosuppressive therapy
11. Prolonged immobilization
12. Patients whose Serum Ca++ level < 2.2 or > 2.6 mmol/L ( < 9 or >10.5 mg/dL)
13. History of renal stones
14. Long bone fracture in last 6 months.
15. Patient not ready to give an informed consent
16. Subjects who has participated in any other clinical study in last 30 days.
17. Patients with clinical evidence of active and chronic illness as rheumatoid arthritis, gout,SLE, Psoriatic arthritis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the safety and efficacy of Grassroots leads with Ayurvedic drug (Lakshadi Guggulu and Praval Pishti) and Allopathic drug(Shalcal) in subject with postmenopausal osteoporosis.Timepoint: 1 year
- Secondary Outcome Measures
Name Time Method Mean changes in quality of life among women suffering from postmenopausal osteoporosisTimepoint: 1 year;To assess the biomarker response for bone formation of study drugs in postmenopausal osteoporosis <br/ ><br>Timepoint: 1 year