None listed
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
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 less than or equal to 26.55. 3.Have a PSS-10 score of greater than or equal to 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
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 |
|---|---|
| Mean change in scores for Female Sexual Function Index (FSFI) from baseline to week 12Timepoint: Baseline, Week 4, Week 8, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in scores for Female Sexual Distress Scale (FSDS) from baseline to week 12Timepoint: Week 4, Week 8, Week 12;Mean change in Global measure of sexual satisfaction (GMSEX) scores from baseline to week 12Timepoint: Week 4, Week 8, Week 12;Mean change in scores for Perceived Stress Scale (PSS) from baseline to week 12Timepoint: Week 4, Week 8, Week 12;Change in Patient-Reported Outcomes Measurement Information System (PROMIS) scores from baseline to week 12Timepoint: Week 4, Week 8, Week 12;Mean Change in Salivary Cortisol Awakening response (CAR) from baseline to Week 12Timepoint: Baseline and Week 12;Mean Change in Bedtime cortisol levels from baseline.Timepoint: Baseline and Week 12;Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline to week 12Timepoint: Baseline, Week 12;Mean change in Thyroid (T3, T4, TSH) parameters from baseline to week 12Timepoint: Baseline, Week 12;Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baseline to week 12Timepoint: Baseline, Week 12;Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 12 weeks.Timepoint: Baseline, Week 4, Week 8, Week 12;Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 12 weeks.Timepoint: Baseline, Week 4, Week 8, Week 12 | — |
Countries
India, United States of America
Contacts
Public ContactDr Mahesh Gupta
Matis Multispecialty Hospital
Outcome results
None listed