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 to 35 kilogram per meter square. 4. Participants and or their legally acceptable representatives who provide written informed assent or 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 during the study period. 7. Must be willing to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1. Participants with menstrual cycle duration less than 24 days or greater than 34 days. 2. Participants taking any form of herbal extract within the last 3 months before study entry. 3. Participants who are on hormone replacement therapy for more than 3 months. 4. Participants with any active medical, surgical, or gynaecological problems. 5. Participants with a history of alcohol dependence, tobacco dependence, or any substance abuse. 6. Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological, or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult. 7. Participants with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 8. Participants showing an uncooperative attitude, including poor compliance. 9. Participants unable to attend follow up visits. 10. Participants with any other medical condition that may, in the opinion of the Investigator, interfere with the study objective. 11. Participants with known hypersensitivity to products containing Shatavari. 12. Participants who have participated in other clinical trials during the previous 3 months. 13. Participants with any clinical condition which, according to the Investigator, does not allow safe fulfilment of the 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 pr1) to week 8 in the daily record ofoblems (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 outcomes.Timepoint: 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 Prashant Ghuge
Shree Vinayak Hospital
Outcome results
None listed