Health Condition 1: N958- Other specified menopausal and perimenopausal disorders
Conditions
Interventions
None listed
Sponsors
MotherSoul Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult menopausal female participants, 40 to 70 years of age (both inclusive). 2. Perimenopausal and postmenopausal participants who are experiencing bothersome Vasomotor Symptoms. Perimenopause is defined as amenorrhea for greater than 60 days in the past 12 months; post menopause is defined as being without a menstrual cycle due to spontaneous reasons for the preceding 12 months. 3. Participants with menopause symptoms, defined as a score of greater than or equal to 9 to less than or equal to 16 in the Menopausal Rating Scale (MRS) at screening (includes both peri-menopausal and post-menopausal women). 4. Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.
Exclusion criteria
Exclusion criteria: 1. Participants with a known history of hypersensitivity to the study medication or any of the ingredients of the formulation. 2. Participants with present active medical, surgical, and gynaecological problems. 3. History of malignancy or any ongoing malignancy. 4. Participants with known history of uncontrolled hypertension and uncontrolled Type 2 Diabetes Mellitus. 5. Participants with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts); or cerebrovascular accident. 6. Participants with clinically relevant current or past history of severe, unstable, or uncontrolled pulmonary, hepatic, endocrine, neurological, rheumatological and renal diseases necessitating medical care. 7. Participants who are on hormone replacement therapy (HRT) for more than 3 months. 8. Participants taking medications such as glucocorticoids, anticonvulsants, antipsychotics, anxiolytics, antidepressants, opioid pain relievers, hypnotics, methotrexate, etc. or any other drugs that may have an influence on the outcome of the study. 9. Participants with sleep disturbances and who are on prescription/over the counter/herbal/nutraceutical or any other system of therapy for sleep related concerns. 10. Participants using phytoherbal supplements, herbal extracts, nutraceuticals, or ayurvedic supplements 3 months prior to screening. 11. Participants who are consuming or planning to consume soy/estrogenic foods like soybean oil or other estrogenic diet supplements. 12. Any other health or mental condition or any significant laboratory parameters that in the investigators opinion may adversely affect the participants ability to complete the study or its measures or that may pose significant risk to the participant. 13. Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 14. Participants who are pregnant or lactating or planning to become pregnant during the study period. Participants who are not ready to use acceptable contraceptive methods during the course of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion in Menopause Rating Scale (MRS) assessment from baseline to end of study.Timepoint: 60 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Menopause Rating Scale (MRS) assessment from baseline to end of study.Timepoint: 60 Days;Mean change in Utian Quality of life Scale (UQOL) assessment from baseline to end of study.Timepoint: 60 Days;Mean change in Depression Anxiety Stress Scale (DASS-21) assessment from baseline to end of study.Timepoint: 60 Days;Mean change in Greene Climacteric Scale assessment from baseline to end of study.Timepoint: 60 Days;Safety Endpoint: The assessment of safety of Investigational Product will be based on incidence of AEs, SAEs and changes in laboratory parameters.Timepoint: 60 Days | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt Ltd
Outcome results
None listed