NCT07861295 Satavari and Ashoka for Menopause (SAM) Study
| NCT ID | NCT07861295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vidya USA Corporation |
| Condition | Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-10-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT07861295 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 65 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07861295 currently recruiting?
Yes, NCT07861295 is actively recruiting participants. Visit ClinicalTrials.gov or contact Vidya USA Corporation to inquire about joining.
Where is the NCT07861295 trial being conducted?
This trial is being conducted at New Port Richey, United States.
Who is sponsoring the NCT07861295 clinical trial?
NCT07861295 is sponsored by Vidya USA Corporation. The trial plans to enroll 50 participants.