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Satavari and Ashoka for Menopause (SAM) Study

Vidya USA Corporation · with MusB Research · NCT07861295

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40–65 · Women only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
50
US sites recruiting
1
Study start
October 1, 2025
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Ashoka Bark and Shatavari; Placebo

Conditions: Menopause

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • MusB Research LLC

    New Port Richey, FL 34653

    Site contact: Prinicipal Investigator · 8134190781 · info@musbdiagnostics.com

All nutrition & metabolism studies in Florida →
Satavari and Ashoka for Menopause (SAM) Study (NCT07861295) | Bored Studies