Evaluation of the effect of aqueous extract of Shilajit on bone health and its biomarkers in post-menopausal women.

izams Institute of Medical Sciences0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

发起方

izams Institute of Medical Sciences