Satavari and Ashoka for Menopause (SAM) Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Ashoka Bark and Shatavari: 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.

Placebo: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Menopausal Rating Scale total score — Baseline (Day 0) to Week 12 (Day 84)
  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.
• Change in Greene Climacteric Scale total score — Baseline (Day 0) to Week 12 (Day
  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.
• Change in Kupperman Menopausal Index total score — Baseline (Day 0) to Week 12 (Day 84)
  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.
• Change in serum follicle-stimulating hormone concentration — Baseline (Day 0) to Week 12 (Day 84)
  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
• Change in serum estradiol concentration — Baseline (Day 0) to Week 12 (Day 84)
  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

Trial sites (1)

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