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| Name | Class |
|---|---|
| Ixoreal Biomed Private Limited | INDUSTRY |
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This randomized, double-blind, placebo-controlled clinical study is designed to evaluate the efficacy and safety of a standardized Shatavari (Asparagus racemosus) root extract (SRI-81) in improving women's sexual wellness. Sexual wellness is assessed as a multidimensional construct encompassing sexual function, sexual distress, sexual satisfaction, perceived stress, quality of life, and physiological stress markers. Participants will receive either Shatavari root extract or placebo for 12 weeks, with assessments conducted at baseline and follow-up visits.
Women's sexual wellness is influenced by biological, psychological, and social factors. Stress and neuroendocrine imbalance play a central role in sexual dysfunction and distress. Shatavari (Asparagus racemosus), a traditional Ayurvedic herb, has been historically used to support female reproductive health, hormonal balance, and stress modulation.
This multi-national, prospective, randomized, double-blind, parallel-group study will enroll women aged 20 to 50 years in India and the United States. Eligible participants with reduced sexual function and elevated perceived stress will be randomized in a 1:1 ratio to receive either SRI-81 Shatavari root extract (300 mg/day) or a matched placebo for 12 weeks.
Efficacy will be primarily assessed using the Female Sexual Function Index (FSFI). Secondary outcomes include sexual distress, sexual satisfaction, perceived stress, quality of life, salivary cortisol measures, and laboratory safety parameters. Safety will be evaluated through adverse event monitoring and laboratory investigations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shatavari Root Extract (SRI-81) 300 mg | Experimental | Participants randomized to this arm will receive a standardized Shatavari (Asparagus racemosus) root extract (SRI-81) capsule containing 300 mg, administered orally once daily after breakfast with water for a duration of 12 weeks. The intervention is intended to evaluate the efficacy and safety of Shatavari root extract in improving women's sexual wellness, including sexual function, sexual distress, sexual satisfaction, perceived stress, quality of life, and physiological stress markers, compared with placebo. |
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| Placebo Capsule (Starch) 300 mg | Placebo Comparator | Participants randomized to this arm will receive an identical placebo capsule containing 300 mg of starch, administered orally once daily after breakfast with water for 12 weeks. The placebo is matched in appearance, color, and packaging to the active intervention to maintain blinding. This arm serves as the comparator for evaluating the efficacy and safety of Shatavari root extract in women's sexual wellness. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shatavari (Asparagus racemosus) Root Extract | Dietary Supplement | The investigational intervention is a standardized Shatavari (Asparagus racemosus Willd.) root extract (SRI-81), manufactured under current Good Manufacturing Practice (cGMP) conditions. Each capsule contains 300 mg of Shatavari root extract with an herb-to-extract ratio of 13:1 and is standardized to contain ≥10% total Shatavarins, quantified by high-performance liquid chromatography (HPLC). Participants will self-administer one capsule orally once daily after breakfast with water for 12 weeks. The product is designed to support stress modulation and neuroendocrine balance, which may contribute to improvements in women's sexual wellness outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Female Sexual Function Index (FSFI) total score | The Female Sexual Function Index (FSFI) is a validated 19-item self-reported questionnaire assessing female sexual function across six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score ranges from 2.0 to 36.0, with higher scores indicating better sexual function (better outcome). This outcome measures the mean change from baseline in FSFI total score, where an increase in score indicates improvement in female sexual function. | Baseline, Week 4, Week 8, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Female Sexual Distress Scale (FSDS) Score | The Female Sexual Distress Scale (FSDS) is a validated patient-reported outcome measure assessing sexually related personal distress in women. The total score ranges from 0 to 52, with higher scores indicating greater sexual distress (worse outcome). This outcome evaluates the mean change from baseline in FSDS total score, where a reduction in score indicates improvement in sexual distress. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Ademola | Contact | 415-845-4638 | jademola@sfinstitute.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Research Institute | Recruiting | San Francisco | California | 94132 | United States |
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| ID | Term |
|---|---|
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Placebo Capsule | Other | The placebo intervention consists of an orally administered capsule containing 300 mg of inert starch. The placebo capsules are identical in size, color, appearance, and packaging to the active Shatavari intervention to ensure double blinding of participants and study personnel. Participants will self-administer one capsule once daily after breakfast with water for 12 weeks. The placebo contains no active herbal or pharmacological ingredients and is used solely for comparison with the investigational Shatavari root extract. |
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| Baseline, Week 4, Week 8, Week 12 |
| Change in Global Measure of Sexual Satisfaction (GMSEX) Score | The Global Measure of Sexual Satisfaction (GMSEX) is a validated instrument consisting of five bipolar adjective pairs, each rated on a 7-point scale. The total score ranges from 5 to 35, with higher scores indicating greater sexual satisfaction (better outcome). This outcome evaluates the mean change from baseline in GMSEX total score, where an increase in score indicates improvement in subjective sexual satisfaction. | Baseline, Week 4, Week 8, Week 12 |
| Change in Perceived Stress Scale (PSS-10) Score | The Perceived Stress Scale-10 (PSS-10) is a validated 10-item questionnaire measuring perceived stress over the previous month. Each item is scored from 0 (never) to 4 (very often). The total score ranges from 0 to 40, with higher scores indicating greater perceived stress (worse outcome). This outcome assesses the mean change from baseline in PSS-10 total score, where a reduction in score indicates improvement in perceived stress. | Baseline, Week 4, Week 8, Week 12 |
| Change in PROMIS-29 Quality-of-Life Scores | The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Profile assesses health-related quality of life across seven domains: physical function, anxiety, depression, fatigue, sleep disturbance, social participation, and pain interference, along with a pain intensity item. Domain scores are standardized T-scores with a mean of 50 and standard deviation of 10 in the reference population. T-scores typically range from approximately 20 to 80. For negatively worded domains (e.g., anxiety, depression, fatigue, sleep disturbance, pain interference), higher scores indicate worse symptoms (worse outcome). For positively worded domains (e.g., physical function, ability to participate in social roles), higher scores indicate better functioning (better outcome). This outcome evaluates the mean change from baseline in PROMIS-29 domain T-scores and summary scores, interpreted according to domain directionality. | Baseline, Week 4, Week 8, Week 12 |
| Change in Salivary Cortisol Awakening Response (CAR) | Salivary cortisol awakening response (CAR) is a physiological marker of hypothalamic-pituitary-adrenal (HPA) axis activity. This outcome evaluates the mean change from baseline in cortisol levels measured immediately upon awakening and 30 minutes post-awakening. | Baseline and Week 12 |
| Change in Bedtime Salivary Cortisol Levels | Bedtime salivary cortisol reflects diurnal cortisol regulation and stress physiology. This outcome evaluates the mean change from baseline in bedtime salivary cortisol levels measured between 9:00 PM and 10:00 PM. | Baseline and Week 12 |
| Change in Thyroid Function Test Parameters (T3, T4, TSH) | Thyroid function will be assessed using serum triiodothyronine (T3), thyroxine (T4), and thyroid-stimulating hormone (TSH). This outcome evaluates mean changes from baseline in thyroid hormone levels to monitor endocrine safety. | Baseline and Week 12 |
| Change in Liver Function Test Parameters | Liver safety will be evaluated using serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and bilirubin. This outcome assesses mean changes from baseline to monitor hepatic safety. | Baseline and Week 12 |
| Change in Renal Function Test Parameters | Renal safety will be evaluated using serum creatinine and blood urea nitrogen (BUN). This outcome assesses mean changes from baseline to evaluate kidney function during the study. | Baseline and Week 12 |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring or worsening after administration of the study intervention. This outcome measures the number and proportion of participants experiencing TEAEs during the study period. | Baseline to Week 12 |
| Incidence of Treatment-Emergent Serious Adverse Events (TESAEs) | Treatment-emergent serious adverse events (TESAEs) include events that result in death, are life-threatening, require hospitalization, or result in significant disability. This outcome measures the number and proportion of participants experiencing TESAEs. | Baseline to Week 12 |
| D004040 |
| Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |