Ashwagandha for Post-Menopausal Health: A Clinical Study

Phase 4

• Registration Number: CTRI/2024/04/065706
• Lead Sponsor: Simran Obhrai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone mass density using DXATimepoint: 0 Month, 2 Months

Secondary Outcome Measures

Name	Time	Method
Sleep Quality, General Wellness, liver function testTimepoint: before (Day 0) and After (Day 60-70)