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Satavari and Ashoka for Menopause (SAM) Study

Sponsor: Vidya USA Corporation • ClinicalTrials.gov ID: NCT07861295

Registry updated: 2026-10-06

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Description

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.

Interventions

Ashoka Bark and Shatavari (Dietary supplement)
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 (Other)
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.

Eligibility criteria

Inclusion Criteria: * Females aged 40-65 years. * Postmenopausal women in good overall health and fulfilling menopausal criteria set at the MRS score more than 5. * Subjects had experienced absence of regular menstrual cycle for at least 3 months. * Willingness to sign consent, follow protocols and regimen intake, as well as maintain normal physical activity and follow study procedures. Exclusion Criteria: * Not on Hormone Replacement Therapy (HRT) or had discontinued HRT at least 12 months before admission to the study. * History of breast cancer, * BMI ≥ 40mg/kg². * Prior removal of both ovaries. * Pregnancy, breastfeeding, or plans for pregnancy. * History of breast or uterine cancer, including hyperplasia, endometrial carcinoma, or cervical neoplasia. * Unstable medical conditions or clinically diagnosed depression requiring treatment. * Self-reported drug or alcohol abuse. * Allergy or sensitivity to herbal ingredients. * Undiagnosed abnormal vaginal bleeding; * A bilateral hysterectomy; * History of chronic alcoholism, * Medication hypersensitivity, or allergy to dietary supplement ingredients; * Acute systemic infection or abnormal laboratory values. * No antibiotics use in past 30 days. * No regular probiotics use in past 30 days.

Conditions

Menopause

Locations

MusB Research LLC — New Port Richey, Florida, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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