Effect of Ashwagandha (Withania Somnifera) Root Extract on the Improvement of Health in Post Menopausal Women: A Prospective, Randomized, Double Blinded, Placebo-Controlled Clinical Trial - NI

Simran Obhrai0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•1. Willing and able to give written informed consent for participation in the study
•2. Age range 45-65 years
•3. Post Menopausal status (defined by >1 yr since last menstrual period)
•4. Ambulatory
•5. Body mass Index (BMI) =18 and =32 kg/m2 at screening
•6. Commitment to not use calcium or vitamin D supplementation that may influence the study outcome
•7. Ability to understand and comply with the requirements of the study

•1. Pre-menopausal or perimenopausal status or surgical menopause
•2. History of chronic immunological or bone-related disorders, kidney disease, cardiovascular disease
•3. History of bariatric surgery or other forms of malabsorption (including documented celiac disease or chronic diarrhoea)
•4. Alcohol abuse
•5. History of use of oral supplement products containing ashwagandha or Calcium, Vitamin D (more than once per week) within 4 weeks prior to baseline
•6. Current use (within the past 8 weeks) of any medication with known influences on the immune or skeletal system (e.g. immune modulation therapy, systemic glucocorticoids, systemic steroid hormones)
•7. Current or past use (within 1 year of starting the study) of denosumab, teriparatide, raloxifene, hormone replacement therapy, calcitonin, or any other anti-resorptive agent used for the prevention and treatment of osteoporosis.
•8. Smoking or use of nicotine-containing products during the last 6 months
•9. Uncontrolled thyroid disease (abnormal blood thyroid stimulating hormone level within the last 12 months and/or changing dose of thyroid replacement therapy within the last 12 months)

发起方

Simran Obhrai