Sexual Wellness, Women Health
Conditions
Keywords
dietary supplement, shatavari
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTShatavari (Asparagus racemosus) Root Extract
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.
OTHERPlacebo Capsule
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.
Sponsors
SF Research Institute, Inc.
Ixoreal Biomed Private Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women between 20 to 50 years of age. 2. Sexually active, attempting sexual activity, or experiencing concerns related to sexual desire or function, with a partner and have a FSFI total score ≤ 26.55. 3. Have a PSS-10 score of ≥ 14 at screening. 4. Women presenting with signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.). 5. Participants who are reliable, honest, compliant, and agree to co operate with all trial evaluations as well as to be able to perform them as per investigator's opinion. 6. Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff. 7. Able to read and write in English or any other vernacular language. 8. No plan to commence new treatments over the study period. 9. Must have the ability and willingness to sign a written informed consent and to comply with all study procedures.
Exclusion criteria
1. Participants taking any form of herbal extract in the last 3 months before study entry. 2. Participants with hormonal imbalance including PCOS, and symptoms of perimenopause and menopause 3. Participants who are on hormone replacement therapy (HRT) for more than 3 months. 4. Participants with any active medical, surgical, or gynaecological problems. 5. Participants with a history of alcohol, tobacco dependence, or any other substance abuse 6. Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult. 7. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 8. Participants with demonstrated inability to comply with the study procedures, including poor compliance. 9. Participants with inability to attend follow-up visits. 10. Patients with known hypersensitivity to Shatavari, or any of the ingredients of study interventions. 11. Patients who had participated in other clinical trials during the previous 3 months. 12. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Female Sexual Function Index (FSFI) total score | Baseline, Week 4, Week 8, Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Female Sexual Distress Scale (FSDS) Score | Baseline, Week 4, Week 8, Week 12 | 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. |
| Change in Global Measure of Sexual Satisfaction (GMSEX) Score | Baseline, Week 4, Week 8, Week 12 | 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. |
| Change in Perceived Stress Scale (PSS-10) Score | Baseline, Week 4, Week 8, Week 12 | 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. |
| Change in PROMIS-29 Quality-of-Life Scores | Baseline, Week 4, Week 8, Week 12 | 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. |
| Change in Salivary Cortisol Awakening Response (CAR) | Baseline and Week 12 | 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. |
| Change in Bedtime Salivary Cortisol Levels | Baseline and Week 12 | 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. |
| Change in Thyroid Function Test Parameters (T3, T4, TSH) | Baseline and Week 12 | 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. |
| Change in Liver Function Test Parameters | Baseline and Week 12 | 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. |
| Change in Renal Function Test Parameters | Baseline and Week 12 | 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. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Baseline to Week 12 | 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. |
| Incidence of Treatment-Emergent Serious Adverse Events (TESAEs) | Baseline to Week 12 | 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. |
Countries
United States
Contacts
CONTACTDr. John Ademola
Outcome results
None listed