NCT07861295 · Vidya USA Corporation
Satavari and Ashoka for Menopause (SAM) Study
(SAM)
What this study is about
This 12-week randomly assigned, compared against an inactive treatment clinical trial will evaluate the effectiveness and safety of a daily taken by mouth supplement containing Ashoka Bark and Shatavari in women experiencing menopausal symptoms. Up to 50 participants will be randomly assigned to receive either the active supplement or placebo, with 40 participants expected to complete the study.
View original scientific 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
DIETARY_SUPPLEMENT
Ashoka Bark and Shatavari
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.
OTHER
Placebo
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.
Primary outcome measures
Change in Menopausal Rating Scale total score
Time frame: Baseline (Day 0) to Week 12 (Day 84)
Change from baseline to Week 12 in menopausal symptom severity measured using the Menopausal Rating Scale (MRS). The MRS consists of 11 items assessing menopausal symptoms. The total score ranges from 0 to 44, with higher scores indicating greater symptom severity. A decrease in MRS total score indicates improvement in menopausal symptom burden.
Change in Greene Climacteric Scale total score
Time frame: Baseline (Day 0) to Week 12 (Day
Change from baseline to Week 12 in menopausal symptom severity measured using the Greene Climacteric Scale (GCS). The total score will be calculated according to the validated scoring method for the instrument. Higher scores indicate greater menopausal symptom severity. A decrease in GCS total score indicates improvement in menopausal symptom burden.
Change in Kupperman Menopausal Index total score
Time frame: Baseline (Day 0) to Week 12 (Day 84)
Change from baseline to Week 12 in menopausal symptom severity measured using the Kupperman Menopausal Index (KMI). The total score is calculated according to the validated KMI scoring method. Higher scores indicate greater menopausal symptom severity. A decrease in KMI total score indicates improvement in menopausal symptom burden.
Change in serum follicle-stimulating hormone concentration
Time frame: Baseline (Day 0) to Week 12 (Day 84)
Change from baseline to Week 12 in serum follicle-stimulating hormone (FSH) concentration. Serum FSH will be measured from blood samples collected at baseline and Week 12. The outcome will be reported as the change in FSH concentration from baseline to Week 12. Unit of Measure - mIU/mL
Change in serum estradiol concentration
Time frame: Baseline (Day 0) to Week 12 (Day 84)
Change from baseline to Week 12 in serum estradiol concentration. Serum estradiol will be measured from blood samples collected at baseline and Week 12. The outcome will be reported as the change in estradiol concentration from baseline to Week 12. Unit of Measure - pg/mL
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New Port Richey, Florida
Collaborators
MusB Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 6, 2026 · Source of record for eligibility and locations