Health Condition 1: N951- Menopausal and female climactericstates
Conditions
Interventions
None listed
Sponsors
Vaidyarathnam Oushadhasala
Eligibility
Inclusion criteria
Inclusion criteria: 1. Females aged 40 to 60 years. 2. Perimenopausal or postmenopausal women with a history of menopausal symptoms for at least 1 month within the last 12 months. 3. Presence of moderate-to-severe menopausal symptoms defined as MRS score 9-15 is moderate and MRS score greater than or equal to 16 is severe. 4. Willing and able to provide written informed consent. 5. Willing to comply with study procedures and visit schedule.
Exclusion criteria
Exclusion criteria: 1. History of psychiatric illness or alcohol dependence. 2. History of surgical menopause. 3. Current or past history of major systemic illness requiring long-term drug treatment (e.g., rheumatoid arthritis, psycho-neuro-endocrine disorders). 4. Current use of hormonal replacement therapy (HRT). 5. Known major organic pathology of the reproductive system (e.g., carcinoma, fibroids, ovarian cysts). 6. Use of any investigational drug within 1 month prior to randomization. 7. Known or suspected malignancy of any type. 8. Pregnant or lactating women. 9. Clinically significant abnormalities in Baseline laboratory values, including: - Liver function-AST or ALT greater than 2.0 Ã? ULN, total bilirubin greater than 1.5 Ã? ULN (or greater than 2.0 Ã? ULN unless known Gilbertâ??s syndrome). - Renal function-eGFR less than 60 mL per min per 1.73 m-square or creatinine above normal range. - Thyroid profile-TSH outside reference range or uncontrolled thyroid disease. - Lipid profile-Triglycerides greater than or equal to 500 mg per dL or LDL-C greater than or equal to 190 mg per dL. 10. Abnormal vitals at Baseline- - Systolic BP greater than or equal to 160 mmHg or Diastolic BP greater than or equal to 100 mmHg. - Resting heart rate outside 50â??100 bpm unless deemed clinically acceptable by the Investigator. - Body temperature greater than or equal to 38.0 degree celsius. 11. Any acute illness or clinically significant abnormality on physical examination at Baseline, in the Investigatorâ??s judgment. 12. Any other condition that, in the Investigatorâ??s opinion, may interfere with study compliance, safety, or data interpretation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Menopausal Rating Scale (MRS) total score from Baseline (Day 0) to Day 90.Timepoint: Day 0 - Visit 1 - (Baseline) Day 15 ±3 Days - Visit 2 Day 30 ±3 Days - Visit 3 Day 60 ±3 Days - Visit 4 Day 90 ±3 Days - Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptom Reduction: o Mean change in MRS total score from Baseline to Day 15, Day 30, and Day 60. 2. Quality of Life Improvements: - Change in Utian Quality of Life (UQOL) scale score from Baseline to Day 90. - Change in Menopause-Specific Quality of Life (MENQOL) scale score from Baseline to Day 90. 3. Safety Assessments: - Number, type, and severity of adverse events (AEs) and serious adverse events (SAEs) throughout the study. - Clinically relevant changes in laboratory parameters (Lipid profile, Thyroid profile, LFT, RFT, Estrogen, FSH, LH) from Baseline to Day 90. - Clinically significant changes in vital signs and physical examination findings during the study period.Timepoint: Day 0 - Visit 1 - (Baseline) Day 15 ±3 Days - Visit 2 Day 30 ±3 Days - Visit 3 Day 60 ±3 Days - Visit 4 Day 90 ±3 Days - Visit 5 | — |
Countries
India
Contacts
Public ContactMs Arpita Malgi
Samahitha Research Solutions
Outcome results
None listed