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Satavari and Ashoka for Menopause (SAM) Study

Recruiting

Shatavari & Ashoka for Menopause (SAM) Study

Who can join

Ages 40 to 65 · Women

Full 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.

About the study

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.

What is being tested

Sponsor: Vidya USA Corporation · Participants: 50 · Started: Oct 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07861295

Locations in the U.S.

FloridaMusB Research LLC, New Port Richey

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.