Health Condition 1: N958- Other specified menopausal and perimenopausal disorders
Conditions
Interventions
None listed
Sponsors
Waleria Healthtech Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participants who are sexually active women 18-45 years of age. Participants who are in a stable relationship with partner for the past 6 months. Participants having regular cycles (24 35 days) for the past 3 months. Participants attempting vaginal intercourse more than 2 or 4 times per month for past 3 months. Participants with BMI - 18.5 29.9 Participants who screened positive for the assessment of Low Libido using Decreased Sexual Desire Screener. Participants complaining of sexual dysfunction, assessed using FSFI scale
Exclusion criteria
Exclusion criteria: Participants using Hormonal contraceptives (especially IUDs, implants, or pills or Oral contraceptives) Participants who are Pregnant / Lactating women Participants who are on anti-depression, anxiety etc- SSRI s etc. Participants undiagnosed with pelvic floor or major endocrine disorder Participants who use recreational drug use or nicotine Participants who consume alcohol more than 7 drinks/week Participants with moderate-to-severe depression, anxiety, bipolar disorder unless stable & treated Participants history of Cancer treatments Participant with sexually transmitted diseases Participants taking any form of herbal extract in the last 3 months before study entry. Participants who are on hormone replacement therapy (HRT) for more than 3 months. Participants with any active medical, surgical, or gynaecological problems. Participants with a history of alcohol, tobacco dependence, or any other substance abuse 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. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Participants with evidence of uncooperative attitude, including poor compliance. Participants with inability to attend follow-up visits. Patients with known hypersensitivity to Shatavari, or any of the ingredients of study medication. Patients who had participated in other clinical trials during the previous 3 months. 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 |
|---|---|
| Mean change in the total score of FSFI (Female sexual function index) FSFI assessment will be done at Visit 1, Screening Visit; Visit 2, Enrolment Visit/ Baseline Visit, (Day 1); Visit 3 (Week 4), and Visit 4- End of study visit, (Week 8).Timepoint: Day 01, Day 7, Day 28 and Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Fatigue Scale- Fatigue Severity Scale (FSS) 2. Serum Hormones (Sr. Estradiol, prolactin, Free testosterone, , Cortisol) will be collected at Enrolment Visit/ Baseline Visit, (Day 1) and Visit 4 - (Day 56) 3.Mean change in the individual domain score of FSFI scale 4.Daily dairy of sexual events during the study period Timepoint: Day 01, Day 7, Day 28 and Day 56 | — |
Countries
India
Contacts
Public ContactDr Madhuchander
Jeevak Hospital - Multispecialt
Outcome results
None listed