None listed
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy women aged 18 40 years with intact uterus and ovaries. 2. Females with complaints of experiencing mild to moderate PMS confirmed by one baseline cycle using the DRSP. 3. PSST scores consistent with PMS and not meeting criteria for severe PMS or PMDD. 4. Body mass index 18-35 kg/m2. 5. Subject who has given written informed consent to participate in the study and understand the nature of the study. 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 within the last 3 months before study entry. 2. Participants who are on hormone replacement therapy for more than 3 months. 3. Participants who are pregnant. 4. Participants with irregular menstrual cycles in the past 12 months, cycle length variability greater than 7 days, 2 or more missed cycles in the past 12 months, or absence of menstruation for 60 days or more. 5. Participants with present active medical, surgical, or gynaecological problems. 6. Participants with a history of alcohol dependence, tobacco dependence, or any substance abuse. 7. Participants who have undergone bilateral ovariectomy. 8. Participants with a history of breast carcinoma or cervical carcinoma. 9. Participants taking medications that affect bone metabolism, including glucocorticoids, anticonvulsants, and methotrexate. 10. Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological, or other major systemic diseases that may make implementation of the protocol or interpretation of the study results difficult. 11. Participants with a mental condition that renders the subject unable to understand the nature, scope, and possible consequences of the study. 12. Participants with demonstrated inability to comply with study procedures or follow up visits. 13. Participants with inability to attend follow up visits. 14. Participants with any other medical condition, for example uncontrolled infection, that may, in the opinion of the Investigator, interfere with the study objective. 15. Participants who have participated in other clinical trials during the previous 3 months. 16. 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 in Daily Record of Severity of Problems (DRSP) total score from baseline cycle to Week 12.Timepoint: Baseline, Week 4, Week 8, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Perceived Stress Scores (PSS) scores from baseline to Week 12.Timepoint: Baseline, Week 4, Week 8, Week 12;Mean change in Pittsburg Sleep Quality Index (PSQI) scores from baseline to Week 12.Timepoint: Baseline, Week 4, Week 8, Week 12;Mean change in Womens Quality of Life Questionnaire (WOMQOL) questionnaire scores from baseline to Week 12.Timepoint: Baseline, Week 4, Week 8, Week 12;Mean change in Bedtime cortisol levels from baseline to Week 12.Timepoint: Baseline and Week 12;Mean change in Cortisol Awakening response (CAR) from baseline to Week 12.Timepoint: Baseline and Week 12;Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline to Week 12.Timepoint: Baseline, Week 12;Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baseline to Week 12.Timepoint: Baseline, Week 12;Mean change in Thyroid (T3, T4, TSH) parameters from baseline to Week 12.Timepoint: 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