Satavari and Ashoka for Menopause (SAM) Study (SAM)
Shatavari & Ashoka for Menopause (SAM) Study
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Menopause is a natural biological transition resulting from the progressive decline of ovarian function and decreased production of estrogen and progesterone. This hormonal transition is commonly accompanied by elevations in follicle-stimulating hormone (FSH) and a wide range of symptoms, including vasomotor symptoms (hot flashes and night sweats), sleep disturbances, mood changes, cognitive complaints, fatigue, urogenital symptoms, and reductions in overall quality of life. Approximately 1.3 million women enter menopause annually in the United States, and nearly 75% experience symptoms that are moderate to severe. The resulting impact on healthcare utilization, work productivity, and quality of life contributes substantially to the national healthcare burden.
Hormonal changes associated with menopause also influence the composition of the vaginal and skin microbiomes. Declining estrogen levels are associated with reductions in Lactobacillus species, altered microbial diversity, decreased epithelial integrity, reduced skin hydration, and increased susceptibility to irritation and infection. Although these biological changes have been increasingly recognized, relatively few interventional studies have evaluated whether botanical therapies influence both menopausal symptoms and the vaginal microbial environment.
Hormone replacement therapy (HRT) remains an effective treatment for many women but is not appropriate or acceptable for all individuals because of contraindications, safety concerns, or personal preference. Consequently, there is growing interest in safe, evidence-based, non-hormonal interventions that may alleviate menopausal symptoms while minimizing treatment-related risks.
Ashoka Bark (Saraca asoca) and Shatavari (Asparagus racemosus) have been used for centuries in traditional systems of medicine to support women's reproductive and hormonal health. Both botanicals contain naturally occurring bioactive compounds with reported phytoestrogenic, antioxidant, anti-inflammatory, and adaptogenic properties that may contribute to improvements in menopausal symptoms. Preliminary evidence suggests these ingredients may support hormonal balance, emotional well-being, sleep quality, and overall quality of life; however, high-quality randomized, placebo-controlled clinical trials remain limited. Additional well-designed clinical research is needed to evaluate their efficacy and safety using standardized outcome measures and objective biological assessments.
The present study has been designed to evaluate a proprietary botanical formulation containing Ashoka Bark and Shatavari ("Beauty Within") in women experiencing menopausal symptoms. The study seeks to determine whether daily supplementation produces clinically meaningful improvements in menopausal symptom severity, hormone profiles, and health-related quality of life compared with placebo in the post-menopausal women. This randomized, placebo-controlled, 12-week clinical trial will evaluate the efficacy and safety of a daily oral supplement containing Ashoka Bark and Shatavari in women with menopausal symptoms. The primary objectives are to assess changes in serum FSH and estradiol levels and improvements in menopausal symptoms measured by the MRS, GCS, and KMI. Secondary objectives include evaluating quality of life using the MENQOL questionnaire and changes in anxiety, cognitive function, and sleep disturbance using PROMIS measures. An exploratory objective will assess changes in the vaginal microbiome following treatment.
Validated patient-reported outcome instruments, including the Menopausal Rating Scale (MRS), Greene Climacteric Scale (GCS), Kupperman Menopausal Index (KMI), Menopause-Specific Quality of Life Questionnaire (MENQOL), and Patient-Reported Outcomes Measurement Information System (PROMIS) measures, provide standardized methods for evaluating symptom severity and health-related quality of life in menopausal women. In addition, laboratory assessment of reproductive hormones, particularly FSH and estradiol, provides objective measures that complement clinical symptom assessment.
The study will be conducted at MusB Research (New Port Richey, Florida) and will randomize up to 50 participants to achieve 40 study completers (20 active treatment and 20 placebo). Participants will attend three study visits over 12 weeks: baseline (Week 0), midpoint (Week 6), and endpoint (Week 12). Assessments include informed consent, eligibility screening, blood collection for FSH and estradiol, validated symptom and quality-of-life questionnaires, safety monitoring, adherence assessment, and optional vaginal microbiome sampling. Participants will take one capsule daily containing either the active botanical formulation or placebo throughout the study.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Florida
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New Port Richey, Florida, Estados Unidos, 34653
- Recrutamento
- MusB Research LLC
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Contato:
- Prinicipal Investigator
- Número de telefone: 8134190781
- E-mail: info@musbdiagnostics.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Ashoka Bark and Shatavari Intervention Arm
Participants assigned to this arm will receive the active investigational supplement containing Ashoka Bark (Saraca asoca) and Shatavari (Asparagus racemosus). Participants will take one capsule daily (100 mg) orally before or during a meal for 12 weeks. The intervention is intended to evaluate the effect of the botanical formulation on menopausal symptoms, hormonal measures, quality of life, and exploratory microbiome outcomes. Participants will complete scheduled study assessments, symptom tracking, safety monitoring, and adherence evaluations throughout the intervention period. |
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.
Outros nomes:
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Comparador de Placebo: Placebo Control Arm
Participants assigned to this arm will receive a matched placebo capsule administered orally once daily before or during a meal for 12 weeks. The placebo will be identical in appearance to the active supplement to maintain blinding. Participants will undergo the same clinical assessments, symptom evaluations, safety monitoring, and adherence assessments as the intervention arm to allow comparison of outcomes between groups. |
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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Menopausal Rating Scale total score
Prazo: 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. |
Baseline (Day 0) to Week 12 (Day 84)
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Change in Greene Climacteric Scale total score
Prazo: 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. |
Baseline (Day 0) to Week 12 (Day
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Change in Kupperman Menopausal Index total score
Prazo: 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. |
Baseline (Day 0) to Week 12 (Day 84)
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Change in serum follicle-stimulating hormone concentration
Prazo: Baseline (Day 0) to Week 12 (Day 84)
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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 |
Baseline (Day 0) to Week 12 (Day 84)
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Change in serum estradiol concentration
Prazo: 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 |
Baseline (Day 0) to Week 12 (Day 84)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Menopause-Specific Quality of Life Questionnaire score
Prazo: Baseline (Day 0) to Week 12 (Day 84)
|
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. |
Baseline (Day 0) to Week 12 (Day 84)
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Change in Patient-Reported Outcomes Measurement Information System Anxiety Short Form 4a score
Prazo: Baseline (Day 0) to Week 12 (Day 84)
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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. |
Baseline (Day 0) to Week 12 (Day 84)
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Change in Patient-Reported Outcomes Measurement Information System Cognitive Function Abilities Short Form 4a score
Prazo: Baseline (Day 0) to Week 12 (Day 84)
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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. |
Baseline (Day 0) to Week 12 (Day 84)
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Change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 4a score
Prazo: Baseline (Day 0) to Week 12 (Day 84)
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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. |
Baseline (Day 0) to Week 12 (Day 84)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Publicações Gerais
- 1. Wallace, R. L., & Okonsky, H. (2018). Management of the perimenopause. Clinical Obstetrics and Gynecology, 61(3), 471-480 2. The current strategy in hormonal and non-hormonal management of menopause. Life, 13(3), 649 3. Correlation among four questionnaires that evaluate menopausal symptoms. Archives of Gynecology and Obstetrics, 306(2), 523-529 4. Hormonal and non- hormonal strategies for managing the perimenopausal period: A short review. Life, 14(1),131. 5. Menopause and cardiovascular disease: A comprehensive review of the pathophysiology, risk assessment, and management strategies. World Journal of Cardiovascular Diseases, 14(3), 164-180. 6. The association of menopausal hormone levels with disease progression in multiple sclerosis. 7. Comparing the efficacy of methylprednisolone pulse therapy in short-term and long-term multiple sclerosis patients: A quasi- experimental study. Multiple Sclerosis and Related Disorders, 75, 104724. 8. The efficacy of natalizumab on motor evoked potential changes in patients with 9. Pregnancy-related clinical outcomes in women with relapsing-remitting multiple sclerosis treated with teriflunomide. Multiple Sclerosis and Related Disorders, 90, 105825. 10. Supplemental digital content 11. Correlation among four questionnaires that evaluate menopausal symptoms. Menopause, 29(8), 953-958. 12. A factor analytic study of climacteric symptoms. Journal of Psychosomatic Research, 20(5), 425-430. 13. Menopause diagnostic tools. Retrieved August 13, 2025, 14. Selection of appropriate biomarkers to monitor effectiveness of ovarian function suppression in pre-menopausal patients with ER+ breast cancer. NPJ Breast Cancer, 10(1), 8. 15. Menopausal Changes in the Microbiome-A Review Focused on the Genitourinary Microbiome. Diagnostics (Basel), 13(6), 1193. 16. The current strategy in hormonal and non-hormonal therapies in menopause-A comprehensive review. Life (Basel), 13(3), 649.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- Menopausa
- Saúde da mulher
- Estradiol
- Suplemento dietético
- Mulheres pós-menopáusicas
- Sintomas vasomotores
- Ondas de calor
- Suplemento de ervas
- Sintomas da menopausa
- Microbioma vaginal
- Suplemento Botânico
- Shatavari
- Asparagus racemosus
- Greene Climacteric Scale
- Non-Hormonal Therapy
- Follicle-Stimulating Hormone
- Ashoka Bark
- Saraca asoca
- Menopausal Rating Scale
- Kupperman Menopausal Index
- Randomized Placebo-Controlled Trial
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB#25-030
- IRB#25-030 (Outro identificador: Sitero IRB)
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