None listed
Conditions
Interventions
None listed
Sponsors
Hirehal Greenspace Herbs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female aged more than or equal to 20 years and less than or equal to 55 years of age. 2.The study will recruiting females aged greater than or equal to 30 primarily. 3.BMI less than 30 kg/m2. 4.Currently in a stable, monogamous sexual relationship with partner with normal libido, with for at least 3 months. 5.Relationship Assessment Scale (RAS) score more than or equal to 15. 6.Estradiol levels less than 150 pg per ml at baseline. 7.Self-reported sexual dysfunction as indicated by FSFI score less than or equal to 20.0. 8.Perceived Stress Scale - 14 score more than 19 9.Individual literate enough to understand and comply with the study procedure. 10.Patients willing to provide written informed consent. Participants should additionally meet following criteria to be included in the cohort II of the study: 1. Females who have not achieved conception despite multiple attempts over the past six months. 2. Anti-mullerian Hormone more than 1.66 ng per ml.
Exclusion criteria
Exclusion criteria: 1.Have received androgen therapy at any time during the past 3 months. 2.Currently on Hormone replacement therapy. 3.Not in stable sexual relationship. 4.History of cancer at any time before study participation. 5.Diagnosed cases of Diabetes or Hypertension. 6.Females currently using any contraceptive method, including oral contraceptive pills (OCPs), intra-uterine devices (IUDs), implants, injectable contraceptives, transdermal patches, or vaginal rings. 7. Known cases of major psychiatric disorders which includes but is not limited to Bipolar disorder, Post-Traumatic Stress Disorder, Schizophrenia, Sexual Aversion Syndrome, psychosis etc. 8.History of early hysterectomy, oophorectomy, physiological conditions (Vaginismus). 9.History of cardiac, gastro, renal, or neurological disease. 10.History of HIV 1 or 2, Hepatitis B or C viruses, and syphilis. 11.History of alcoholism i.e. alcohol consumption greater than 2 units / day or10 units / week (one unit of alcohol equal to 50 ml spirit or 200 ml wine or 500ml beer). 12.History of smoking or Tobacco consumption. Participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Female Sexual Function Index (FSFI) Score. Timepoint: Baseline, Day 7, End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Sexual Desire Inventory-2 Female Sexual Distress Scale-Revised Pain Numeric Rating Scale Sexual Activity and Satisfaction Scale Sexual Quality of Life-Female Serum Estradiol levels Serum Progesterone levels Free Testosterone LevelsTimepoint: Baseline and End of Study;Cohort - II Rate of spontaneous pregnancyTimepoint: Throughout the study;Cohort - II Mid cycle Luteinizing Hormone (LH) surge Anti-M llerian Hormone (AMH)Timepoint: Baseline and End of Study | — |
Countries
India
Contacts
Public ContactDr Shalini Srivastava
Bioaxion Innovation
Outcome results
None listed