Health Condition 1: null- Postmenopausal women with joint pains in lower extremities Health Condition 2: Z729- Problem related to lifestyle, unspecified
Conditions
Interventions
Intervention1: Capsule shilajit 250 mg: given once daily per oral
Intervention2: Capsule shilajit 500 mg: given once daily per oral
Control Intervention1: identical placebo (capsule) similar to Capsul
Sponsors
Nizams Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women (Age: 45 - 60 yrs) - menopause is defined as having no menstrual period for 12 consecutive months by, "The American College of Obstetricians and Gynecologists - ACOG". 2. Absence of menstrual period for 12 months but not more than 5 years. 3. Normal function of thyroid, liver and kidney. 4. Serum 25-hydroxy vitamin D >=20 ng/mL. 5. No bisphosphonates at all if they had a treatment lasting at least 12 months. 6. Bone mass with BMD T-score >â??2.5 (non-osteoporotic) at measured site (spine and/or hip) using DEXA - for subjects willing to undergo DEXA scan.
Exclusion criteria
Exclusion criteria: 1. History of, or evidence for, metabolic bone disease including recent fractures 2. Having received medication (calcitonin, raloxifene or systemic glucocorticoids) within 3 months of the study initiation. 3. Having hormone/hormone-like replacement therapy within 6 months of the study initiation. 4. History of cancer within the past 5 years. 5. Glycated haemoglobin of >=8% in the past 3 months. 6. History of statin or other drugs for cholesterol control within 3 months of the study initiation. 7. Smoking / chewing tobacco /alcohol intake, use of non-steroidal anti-inflammatory drugs on a regular basis. 8. Body mass index (BMI) less than 20 or greater than 32.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in CTX, BAP, sRANKL, OPG levels from baseline to the end of 24 weeks of treatment. 2. Change in biomarkers of oxidative stress from baseline to the end of 24 weeks of treatment. Timepoint: 0,4,12,24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of subjects whose serum CTX and BAP levels have decreased by 50% following treatment at the end of 24 weeks. 2. Measurements of tolerability will be assessed at the end of 24 weeks (a) Good â?? no serious side effects (b) Fair â?? mild to moderate side effects (c) Poor â?? severe side effects and withdrawal of therapy. Timepoint: 0,4,12,24 weeks | — |
Countries
India
Contacts
Public ContactDr P USHARANI
NIZAMS INSTITUTE OF MEDICAL SCIENCES
Outcome results
None listed