None listed
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Menopausal women aged 40 to 55 years with intact uterus and ovaries. 2.Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months or reported menopause for at least 60 days. 3.Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc. 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 in the last 3 months before study entry. 2.Participants who are on hormone replacement therapy (HRT) for more than 3 months. 3.Participants with Present active medical, surgical, and gynaecological problems. 4.Participants with a history of alcohol, tobacco dependence, or any substance abuse. 5.Participants who had undergone bilateral ovariectomy 6.Participants with history of breast or cervical carcinoma 7.Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate. 8.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. 9.Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 10.Participants with evidence of uncooperative attitude, including poor compliance. 11.Participants with inability to attend follow-up visit 12.Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective. 13.Patients who had participated in other clinical trials during the previous 3 months. 14.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 score for Menopause Rating Scale (MRS) from baseline.Timepoint: Baseline, Week 4, Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Hot Flashes event from baseline.Timepoint: Baseline, Week 4, Week 8;Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline.Timepoint: Baseline, Week 8;Mean change in Menopause Symptoms Treatment Questionnaire (MENQOL) scores from baseline.Timepoint: Baseline, Week 4, Week 8;Mean change in Profile of Mood States (POMS, abbreviated version) questionnaire scores from baseline.Timepoint: Baseline, Week 4, Week 8;Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baseline.Timepoint: Baseline, Week 8;Mean change in scores for Perceived Stress Scale (PSS) questionnaire from baseline.Timepoint: Baseline, Week 4, Week 8;Mean change in Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) levels from baseline.Timepoint: Baseline, Week 8;Mean change in Thyroid (T3, T4, TSH) parameters from baseline.Timepoint: Baseline, Week 8;Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks.Timepoint: Baseline, Week 4, Week 8;Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeks.Timepoint: Baseline, Week 4, Week 8 | — |
Countries
India
Contacts
Public ContactDr Supriya Mahajan
Sr. Consultant
Outcome results
None listed