None listed
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Females aged 13 to 20 years 2. Post-menarche girls and young women with menarche occurring at least 12 months prior to enrolment-to avoid very early physiologic irregularity. 3. Body mass index 18 35 kg per metre square 4. Participants and/or their legally acceptable representatives - LAR who provide written informed assent/consent to participate in the study 5. Able to read and write in English or any other vernacular language 6. No plan to commence new treatments over the study period 7. Must be willing to comply with all study procedures
Exclusion criteria
Exclusion criteria: 1. Menstrual cycle duration to less than 24 days or greater than 34 days 2. Participants taking any form of herbal extract in the last 3 months before study entry 3. Participants who are on hormone replacement therapy - HRT for more than 3 months 4. Presence of any active medical, surgical and gynaecological problems 5. History of alcohol, tobacco dependence, or any 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 suggestive of uncooperative attitude, including poor compliance 9. Unable to attend follow-up visit 10. Presence of any other medical condition that may, in the opinion of the Investigator, interfere with the study objective 11. Known hypersensitivity to products containing Shatavari 12. Participated in other clinical trials during the previous 3 months 13. 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 from baseline (cycle-1) to week 8 in the daily record of severity of menstrual and hormonal health-related problems (DRSP)Timepoint: Baseline (Cycle-1), Week 4 (Cycle-2), Week 8 (Cycle-3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline to week 12 in DASS-21 (Depression, Anxiety, Stress Scale) scoreTimepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 8 in the pain scores (worst pain during the menstrual cycle) measured on a 0 10 NRS (Numerical Rating Scale)Timepoint: Baseline (Cycle-1), Week 4 (Cycle-2), Week 8 (Cycle-3);Mean change from baseline to week 12 in the scores of Global Acne Grading System (GAGS) to capture hormonal acne outcomesTimepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in the number of days of absenteeism or loss of work in previous 4 weeks periodTimepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in the scores International Physical Activity Questionnaire Short Form (IPAQ-SF)Timepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in the scores Food frequency Questionnaire (FFQ)Timepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in serum sex hormones (Sr. Estradiol-E2, Follicle-Stimulating Hormone, Luteinizing Hormone, Progesterone, Testosterone)Timepoint: Baseline and Week 12;Mean change from baseline to week 12 in salivary cortisol (AM/PM)Timepoint: Baseline and Week 12;Mean change from baseline to week 12 in hepatic parameters (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin)Timepoint: Baseline and Week 12;Mean change from baseline to week 12 in the renal parameters (serum creatinine, blood urea nitrogen)Timepoint: Baseline and Week 12;Mean change from baseline to week 12 in thyroid parameters (T3, T4, TSH)Timepoint: Baseline and Week 12;Proportion of patients experiencing (TEAEs) over 12 weeksTimepoint: Baseline, Week 4, Week 8, Week 12;Proportion of patients experiencing Treatment-Emergent Serious Adverse Events (TESAEs) over 12 weeksTimepoint: Baseline, Week 4, Week 8, Week 12 | — |
Countries
India, United States of America
Contacts
Public ContactDr Amit Mutha
Androme TaX, Mens Health Clinic
Outcome results
None listed