Clinical Study to see the effect of an Ayurvedic Formulation in Osteopenia/Osteoporosis
- Conditions
- Health Condition 1: null- Osteopenia/Osteoporosis (BMD T score between -1 to -3)
- Registration Number
- CTRI/2015/01/005406
- Lead Sponsor
- Central Council for Research in Ayurvedic Sciences CCRAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
1. B.M.D -T. Score between ( -1 to -3 ) on DEXA Scan.
2. Willing and able to participate for 14 weeks
1.Patients who are consuming corticosteroids (more than 5mg/day of prednisolone or equivalent) for more than 3 months
2.Patients with history of Fragility Fracture.
3.Patients suffering from congenital disorders related to bone (Dysosteogenesis, Marfanâ??s Syndrome, etc.)
4.Patients with (Hypothyroidism and Hyperthyroidism, Hypoparathyroidism and Hyperparathyroidism, Cushingâ??s syndrome)
5.Patients with unstable CV diseases
6.Patients suffering from Osteomalacia.
7.Patients suffering from Malabsorption syndrome
8. Patients who have undergone Organ transplantation
9.Patients who are immobilized since > 6 weeks
10.Patients with history of bone fracture in last 6 months.
11.Patients with concurrent serious cardiac, 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.
12.Patients with Diabetes MellitusBlood sugar (fasting >126 and PP >200mg/dl)
13.Alcoholics and/or drug abusers.
14.Patients with evidence of malignancy
15.Patients suffering from major systemic illness necessitating long term drug treatment/Auto-Immune disorders (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
16.Pregnant or lactating woman.
17.H/o hypersensitivity to any of the trial drugs or their ingredients
18.Patients who have completed participation in any other clinical trial during the past
Six (06) months.
19.Patients on calcium and Vitamin D supplementation.
20.Patients with history of Urolithiasis.
21.Known cases of Pagetâ??s disease of bone
22.Any other condition which the investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Serum - Osteocalcin level from Baseline to end of studyTimepoint: At Baseline and and 84th day
- Secondary Outcome Measures
Name Time Method Change in Bone Specific Alkaline PhosphataseTimepoint: At Baseline and and 84th day;Change in Quality of Life index (QUALEFFO-41)Timepoint: At Baseline, at the end of 12 weeks and end of 14 weeks