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Ashwagandha for Post-Menopausal Health: A Clinical Study

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 - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065706
Enrollment
60
Registered
2024-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Simran Obhrai
Lead Sponsor
MYAS GNDU
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
Bone mass density using DXATimepoint: 0 Month, 2 Months

Secondary

MeasureTime frame
Sleep Quality, General Wellness, liver function testTimepoint: before (Day 0) and After (Day 60-70)

Countries

India

Contacts

Public ContactSimran Obhrai

MYAS-GNDU Department of Sports Sciences and Medicine

shweta.myas@gndu.ac.in9760118899

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026