No phaseRecruitingAge-related condition
Satavari and Ashoka for Menopause (SAM) Study
Shatavari & Ashoka for Menopause (SAM) Study
- Sponsor
- Vidya USA Corporation (Industry)
- Enrolment
- 50 planned
- Conditions
- Menopause
- Interventions
- Ashoka Bark and Shatavari; Placebo
- Ages
- adults, older adults
- Registry
- NCT07861295
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change in Menopausal Rating Scale total score
- Change in Greene Climacteric Scale total score
- Change in Kupperman Menopausal Index total score
- Change in serum follicle-stimulating hormone concentration
History
Study completion expected
Primary completion expected
Registered
Started