NCT07861295|Recruiting
Satavari and Ashoka for Menopause (SAM) Study
SAM
Shatavari & Ashoka for Menopause (SAM) Study
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SAM
Shatavari & Ashoka for Menopause (SAM) Study
Sponsor study identifier
Secondary identifiers
OTHER · Sitero IRB
interventional
50
1 country
1
Study Start
October 1, 2025
Actual (reported)Primary Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This 12-week randomized, placebo-controlled clinical trial will evaluate the efficacy and safety of a daily oral supplement containing Ashoka Bark and Shatavari in women experiencing menopausal symptoms. Up to 50 participants will be randomized to receive either the active supplement or placebo, with 40 participants expected to complete the study. Participants will attend visits at Weeks 0, 6, and 12, where hormone levels (FSH and estradiol), menopausal symptoms, quality of life, anxiety, cognitive function, and sleep will be assessed using validated measures. The study will also explore changes in the vaginal microbiome and monitor safety and adherence throughout the trial. The study will be conducted at MusB Research in New Port Richey, Florida.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2025
Actual (reported)September 1, 2026
Actual (reported)October 6, 2026
Actual (reported)December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Menopausal Rating Scale total score
Change from baseline to Week 12 in menopausal symptom severity measured using the Menopausal Rating Scale (MRS). The MRS consists of 11 items assessing menopausal symptoms. The total score ranges from 0 to 44, with higher scores indicating greater symptom severity. A decrease in MRS total score indicates improvement in menopausal symptom burden.
Baseline (Day 0) to Week 12 (Day 84)
Change in Greene Climacteric Scale total score
Change from baseline to Week 12 in menopausal symptom severity measured using the Greene Climacteric Scale (GCS). The total score will be calculated according to the validated scoring method for the instrument. Higher scores indicate greater menopausal symptom severity. A decrease in GCS total score indicates improvement in menopausal symptom burden.
Baseline (Day 0) to Week 12 (Day
Participants assigned to this arm will receive the active investigational supplement containing Ashoka Bark (Saraca asoca) and Shatavari (Asparagus racemosus). Participants will take one capsule daily (100 mg) orally before or during a meal for 12 weeks. The intervention is intended to evaluate the effect of the botanical formulation on menopausal symptoms, hormonal measures, quality of life, and exploratory microbiome outcomes. Participants will complete scheduled study assessments, symptom tracking, safety monitoring, and adherence evaluations throughout the intervention period.
Participants assigned to this arm will receive a matched placebo capsule administered orally once daily before or during a meal for 12 weeks. The placebo will be identical in appearance to the active supplement to maintain blinding. Participants will undergo the same clinical assessments, symptom evaluations, safety monitoring, and adherence assessments as the intervention arm to allow comparison of outcomes between groups.
The intervention is an oral botanical dietary supplement containing Ashoka Bark (Saraca asoca) and Shatavari (Asparagus racemosus) intended for the management of menopausal symptoms. Participants will consume one capsule daily (100 mg) before or during a meal for 12 weeks. The formulation is being evaluated for its potential effects on menopausal symptom severity, hormone-related measures, quality of life, and related health outcomes in postmenopausal women. The intervention will be compared with a matched placebo under randomized, double-blind study conditions. Safety, adherence, and tolerability will be monitored throughout the study period.
MusB Research LLC
New Port Richey, Florida, 34653, United States
1. Wallace, R. L., & Okonsky, H. (2018). Management of the perimenopause. Clinical Obstetrics and Gynecology, 61(3), 471-480 2. The current strategy in hormonal and non-hormonal management of menopause. Life, 13(3), 649 3. Correlation among four questionnaires that evaluate menopausal symptoms. Archives of Gynecology and Obstetrics, 306(2), 523-529 4. Hormonal and non- hormonal strategies for managing the perimenopausal period: A short review. Life, 14(1),131. 5. Menopause and cardiovascular disease: A comprehensive review of the pathophysiology, risk assessment, and management strategies. World Journal of Cardiovascular Diseases, 14(3), 164-180. 6. The association of menopausal hormone levels with disease progression in multiple sclerosis. 7. Comparing the efficacy of methylprednisolone pulse therapy in short-term and long-term multiple sclerosis patients: A quasi- experimental study. Multiple Sclerosis and Related Disorders, 75, 104724. 8. The efficacy of natalizumab on motor evoked potential changes in patients with 9. Pregnancy-related clinical outcomes in women with relapsing-remitting multiple sclerosis treated with teriflunomide. Multiple Sclerosis and Related Disorders, 90, 105825. 10. Supplemental digital content 11. Correlation among four questionnaires that evaluate menopausal symptoms. Menopause, 29(8), 953-958. 12. A factor analytic study of climacteric symptoms. Journal of Psychosomatic Research, 20(5), 425-430. 13. Menopause diagnostic tools. Retrieved August 13, 2025, 14. Selection of appropriate biomarkers to monitor effectiveness of ovarian function suppression in pre-menopausal patients with ER+ breast cancer. NPJ Breast Cancer, 10(1), 8. 15. Menopausal Changes in the Microbiome-A Review Focused on the Genitourinary Microbiome. Diagnostics (Basel), 13(6), 1193. 16. The current strategy in hormonal and non-hormonal therapies in menopause-A comprehensive review. Life (Basel), 13(3), 649.
Change in Kupperman Menopausal Index total score
Change from baseline to Week 12 in menopausal symptom severity measured using the Kupperman Menopausal Index (KMI). The total score is calculated according to the validated KMI scoring method. Higher scores indicate greater menopausal symptom severity. A decrease in KMI total score indicates improvement in menopausal symptom burden.
Baseline (Day 0) to Week 12 (Day 84)
Change in serum follicle-stimulating hormone concentration
Change from baseline to Week 12 in serum follicle-stimulating hormone (FSH) concentration. Serum FSH will be measured from blood samples collected at baseline and Week 12. The outcome will be reported as the change in FSH concentration from baseline to Week 12. Unit of Measure - mIU/mL
Baseline (Day 0) to Week 12 (Day 84)
Change in serum estradiol concentration
Change from baseline to Week 12 in serum estradiol concentration. Serum estradiol will be measured from blood samples collected at baseline and Week 12. The outcome will be reported as the change in estradiol concentration from baseline to Week 12. Unit of Measure - pg/mL
Baseline (Day 0) to Week 12 (Day 84)
Change in Menopause-Specific Quality of Life Questionnaire score
Baseline (Day 0) to Week 12 (Day 84)
Change in Patient-Reported Outcomes Measurement Information System Anxiety Short Form 4a score
Baseline (Day 0) to Week 12 (Day 84)
Change in Patient-Reported Outcomes Measurement Information System Cognitive Function Abilities Short Form 4a score
Baseline (Day 0) to Week 12 (Day 84)
Change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 4a score
Baseline (Day 0) to Week 12 (Day 84)
Matched placebo capsule containing inactive ingredients, administered orally once daily before or during a meal for 12 weeks. The placebo is identical in appearance to the active Ashoka Bark and Shatavari supplement to maintain blinding of participants, investigators, and outcome assessors. The placebo contains no active botanical ingredients and is used as the comparator to evaluate the effects of the Ashoka Bark and Shatavari intervention on menopausal symptoms and related outcomes.
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First Submitted
September 1, 2026
First Posted
October 6, 2026
Study Start
October 1, 2025
Actual (reported)Primary Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 6, 2026
Record last verified: 2026-09
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