None listed
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Women between 18 to 55 years of age. 2.Women willing to have 4 or more attempts of sexual intercourse each month. 3.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.). 4.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. 5.Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff. 6.Able to read and write in English or any other vernacular language. 7.No plan to commence new treatments over the study period. 8.Must have the ability and willingness to sign an informed consent and to comply with all study procedures
Exclusion criteria
Exclusion criteria: 1.Participants taking any form of herbal extract in the last 3 months before study entry. 2.Participants who are on hormone replacement therapy (HRT) for more than 3 months. 3.Participants with any active medical, surgical, or gynaecological problems. 4.Participants with a history of alcohol, tobacco dependence, or any other substance abuse 5.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. 6.Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 7.Participants with evidence of uncooperative attitude, including poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in scores for Female Sexual Function Index (FSFI) from baseline.Timepoint: Mean change in scores for Female Sexual Function Index (FSFI) from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline.Timepoint: Baseline, Week 8;Mean change in Oxford Happiness Questionnaire (OHQ) scores from baseline.Timepoint: Baseline, Week 4, Week 8;Mean change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire from baseline.Timepoint: Baseline, Week 4, Week 8;Mean change in Profile of Mood States (POMS, abbreviated version) questionnaire scores from baselineTimepoint: Baseline, Week 4, Week 8;Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baseline.Timepoint: Baseline, Week 8;Mean change in scores for Female Sexual Distress Scale (FSDS) from baseline.Timepoint: Baseline, Week 4, Week 8;Mean change in scores for Satisfying Sexual Events (SSEs) from baseline.Timepoint: Baseline, Week 4, Week 8;Mean change in Serum Hormones (Sr. Estradiol, FSH, LH, Testosterone) levels from baseline.Timepoint: Baseline, Week 8;Mean change in Thyroid (T3, T4, TSH) parameters from baseline.Timepoint: Baseline, Week 8;Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks.Timepoint: Baseline, Week 4, Week 8;Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeks.Timepoint: Baseline, Week 4, Week 8 | — |
Countries
India
Contacts
Public ContactDr Suprlya Mahajan
Tieten Medi city Hospital
Outcome results
None listed