None listed
Conditions
Interventions
Intervention1: Standardized Shatavari root extract ASPURUS (250 mg/capsule): Standardized Shatavari root extract ASPURUS (250 mg/capsule)
Dose- one capsule of 250 mg, orally, a day, for 12 weeks
Contr
Sponsors
Waleria Healthtech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy females aged between 45 and 65 years with a Body mass index of approximately 24 and 29 and are at present in a stable sexual relationship more than more than 6 months. 2. Women with menopausal symptoms, absence of menstrual cycle for past 12-months (not more than 5 years after menopause start), follicle-stimulating hormone (FSH) more than 30 mIU/mL; estradiol less than 30 pg/mL. 3. Diagnosed with suboptimal sexual function using tools like the Female Sexual Function Index (FSFI) score less than 26.55, along with self report decrease in sexual desire over the past 3-6 months and having more than 1 sexual attempt/activity in past 4 weeks. 4. Have at least 1-2 symptoms affecting intimate comfort like vaginal dryness, discomfort or pain during intimacy, reduced lubrication, decreased satisfaction. Participants may report bother or concern related to sexual function. 5. Have self-reported at least four - five moderate to severe hot flashes per day (including night sweats), or or 28 of mild to moderate hot flashes per week (including night sweats), on average for 7 days 6. Must also be experiencing at least two symptoms of menopause, such as sleep disturbances, hot flashes, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, weight gain, or vaginal changes. 7. Normal vital signs, including electrocardiogram and laboratory evaluations within the reference range for the testing laboratory. 8. In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product. 9. Agree to refrain from treatments for hot flashes and other symptoms of menopause. 10. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Exclusion criteria
Exclusion criteria: 1. Medical History: Past history of breast cancer, coronary heart disease, venous thromboembolic events, or stroke. 2. Active Conditions: Severe depression, uncontrolled or treatment-resistant hypertension, untreated thyroid dysfunction, or severe comorbidities (e.g., kidney failure, dementia). 3. Recent Treatments: Use of hormone replacement therapy (HRT) within 3 months prior to the study. 4. Uterine Health: Unexplained uterine bleeding within 6 months 5. Allergic reaction: to the test product 6. Women with severe dyspareunia as primary cause 7. Untreated severe GSM (e.g., vaginal atrophy grade 3) 8. Induced menopause through surgery such as bilateral oophorectomy or salpingo oophorectomy, chemotherapy, radiation, or drugs. 9. Individuals who have had a partial or total hysterectomy. 10. Use of any treatment for menopausal symptoms in the past three months prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary outcome measures will be considered. 1. Total Score/Symptoms: Changes in the total score/ individual symptoms of FSFI-19+FSDS R and further post-menopausal symptoms at day 28, day 56 and day 84 as compared to baseline (day 0).Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in the Serum levels of estradiol, FSH, LH and Testosterone score on daily basis (24 hours) in the subject diary from baseline to end of treatment (12 weeks). 2. Changes in the hot flushes score on daily basis (24 hours) in the subject diary from baseline to end of treatment (12 weeks). 3. Changes in the Insomnia score on daily basis (24 hours) in the subject diary from baseline to end of treatment (12 weeks). 4. Change in the Fatigue Severity Scale (FSS) Score at day 28, day 56 and day 84 as compared to baseline. 5. Satisfaction with treatment captured using Menopause Symptom Severity Inventory (MSSI- 38) and Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) from baseline to end of treatment (12 weeks).Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Sheetal Patil
Shrigiri Hospital and Heart Care Centre
Outcome results
None listed