Effect of Shilajit on bone health in wome
- Conditions
- Health Condition 1: null- Postmenopausal women with joint pains in lower extremitiesHealth Condition 2: Z729- Problem related to lifestyle, unspecified
- Registration Number
- CTRI/2018/04/013529
- Lead Sponsor
- izams Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method