Health TrialsbyHealthPanel

Satavari and Ashoka for Menopause (SAM) Study

ConditionMenopause
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorVidya USA Corporation

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ashoka Bark and Shatavari

    Dietary supplement

    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.

  • Placebo

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Ashoka Bark and Shatavari Intervention ArmExperimental treatment 1 intervention
Group B: Placebo Control ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Menopausal Rating Scale total score

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.

Time frame
Baseline (Day 0) to Week 12 (Day 84)
2

Change in Greene Climacteric Scale total score

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.

Time frame
Baseline (Day 0) to Week 12 (Day
3

Change in Kupperman Menopausal Index total score

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.

Time frame
Baseline (Day 0) to Week 12 (Day 84)
4

Change in serum follicle-stimulating hormone concentration

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

Time frame
Baseline (Day 0) to Week 12 (Day 84)

Secondary outcomes

1

Change in Menopause-Specific Quality of Life Questionnaire score

Change from baseline to Week 12 in menopause-related quality of life measured using the Menopause-Specific Quality of Life Questionnaire (MENQOL). The score will be calculated according to the validated scoring method for the instrument. Higher scores indicate greater symptom impact and poorer menopause-related quality of life.

Time frame
Baseline (Day 0) to Week 12 (Day 84)
2

Change in Patient-Reported Outcomes Measurement Information System Anxiety Short Form 4a score

Change from baseline to Week 12 in anxiety symptoms measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 4a. The score will be reported using the instrument's standardized scoring method. Higher scores indicate greater anxiety severity.

Time frame
Baseline (Day 0) to Week 12 (Day 84)
3

Change in Patient-Reported Outcomes Measurement Information System Cognitive Function Abilities Short Form 4a score

Change from baseline to Week 12 in perceived cognitive function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Abilities Short Form 4a. The score will be reported using the instrument's standardized scoring method. Higher scores indicate better perceived cognitive function.

Time frame
Baseline (Day 0) to Week 12 (Day 84)
4

Change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 4a score

Change from baseline to Week 12 in sleep disturbance measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 4a. The score will be reported using the instrument's standardized scoring method. Higher scores indicate greater sleep disturbance.

Time frame
Baseline (Day 0) to Week 12 (Day 84)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vidya USA Corporation

Lead sponsor

MusB Research

Collaborator

Source ClinicalTrials.gov
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