None listed
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Menopausal women aged more than 40 to 45 years with intact uterus and ovaries. 2. Participants with complaints of irregular menstrual cycles during the past 12 months, with advancement or delay of the cycle by more than 7 days. At least 2 cycles should have been missed during the past 12 months or menopause reported for at least 60 days. 3. Females having at least two menopausal symptoms such as hot flashes, night sweats, mood swings, sleep disturbances, or breast tenderness. 4. Body mass index between 18 and 35 kilogram per square meter. 5. Subjects who have provided written informed consent to participate in the study and understand the nature of the study. 6. Subjects able to read and write in English or any other vernacular language. 7. Subjects with no plan to start any new treatment during the study period. 8. Subjects willing and able to sign informed consent and comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1. Participants who have taken any herbal extract during the last 3 months before study entry. 2. Participants receiving hormone replacement therapy for more than 3 months. 3. Pregnant participants. 4. Participants with active medical, surgical, or gynaecological disorders. 5. Participants with a history of alcohol dependence, tobacco dependence, or substance abuse. 6. Participants who have undergone bilateral ovariectomy. 7. Participants with a history of breast carcinoma or cervical carcinoma. 8. Participants taking medications affecting bone metabolism, including glucocorticoids, anticonvulsants, or methotrexate. 9. Participants with clinically significant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological, or other major systemic diseases that may interfere with protocol implementation or interpretation of study results. 10. Participants with mental conditions that make them unable to understand the nature, scope, or possible consequences of the study. 11. Participants with evidence of inability to follow study protocols or attend follow up visits, including poor compliance. 12. Participants with demonstrated inability to follow study protocols or attend follow up visits. 13. Participants unable to attend follow up visits. 14. Participants with any medical condition, such as uncontrolled infection, which in the opinion of the investigator may interfere with the study objectives. 15. Participants who have participated in another clinical trial during the previous 3 months. 16. Participants with any clinical condition which, in the opinion of the investigator, may not allow safe participation in the clinical trial protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Menopause Rating Scale (MRS) total score from baseline to week 12Timepoint: Change in Menopause Rating Scale (MRS) total score from baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Menopause-specific Quality of Life Questionnaire (MENQOL) scores from baselineTimepoint: Baseline, Week 4, Week 8, Week 12;Change in Hot Flash-Related Daily Interference Scale (HFRDIS) scores from baselineTimepoint: Baseline, Week 4, Week 8, Week 12;Change in Perceived Stress Scores (PSS) scores from baselineTimepoint: Baseline, Week 4, Week 8, Week 12;Change in Pittsburg Sleep Quality Index (PSQI) scores from baselineTimepoint: Baseline, Week 4, Week 8, Week 12;Change in Profile of Mood States (POMS) scores from baselineTimepoint: Baseline, Week 4, Week 8, Week 12;Change in Salivary Cortisol Awakening response (CAR) from baselineTimepoint: Baseline and Week 12;Change in Bedtime cortisol levels from baselineTimepoint: Baseline and Week 12 | — |
Countries
India, United States of America
Contacts
Public ContactDr Mahesh Gupta
Matis Multispecialty Hospital
Outcome results
None listed