Health Condition 1: N951- Menopausal and female climactericstates
Conditions
Interventions
Intervention1: UBPN01: 1000mg of UBPN01 Soft capsules twice a day orally with water (total 600 mg of
UBPN01 per day) for 12 weeks
Control Intervention1: Placebo: 1000mg of Placebo Soft capsules twice
Sponsors
UNDBIO Pharma Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female between 40 to 60 years (both inclusive) of age at the time of enrolment. 2. Female who are in the state of menopause (amenorrhea for 12 consecutive months) or transition to menopause (for FSH > 30 IU/L without menstruation for more than 3 months) 3. Female with moderate to severe menopausal symptoms (modified Kupperman Index total score >= 25 point) 4. A person who agrees to participate in this study and signs a written consent
Exclusion criteria
Exclusion criteria: 1. Women with a body mass index (BMI) greater than 30 kg / m2 2. Women undergoing HRT (Hormone Replacement Therapy) treatment to relieve menopausal symptoms within 1 month 3. Women taking the following food supplements to relieve menopausal symptoms within 1 month. The food can be a part of regular meal. Though, if any food is being used as a remedy or medication to relieve symptoms, it will be considered as exclusion criteria: Phytoestrogen containing food, Vitamins, Herb extract, Ginseng product, Omega 3, DHEA, Gamma linoleic acid. 4. Women with a history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast cancer or breast disease, sex hormone related cancer 5. A woman with a history of severe migraine within the past year or who has been diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or underwent coronary angioplasty 6. Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants 7. Women with irregular uterine bleeding after 1 year of menopause 8. Patients with uncontrolled hypertension (160 /100mmHg or more, After 10 minutes of stabilization) 9. Uncontrolled diabetes mellitus patients (fasting blood sugar more than 180mg/dL or starting a new drug due to diabetes within 3 months) 10. Patients with thyroid disease whose TSH is less than or equal to 0.1 μU / ml or more than 10 μU / ml 11. drug or alcohol abuser 12. If ALT or AST exceeds 3 times the normal upper limit of the research institute 13. Creatinine exceeds twice the normal upper limit of research institute 14. If a clinically significant abnormality is confirmed by mammography (BI-RADS: Breast Imaging-Reporting and data system Category 0 or 3 or higher. However, in case of BI-RADS category 0, registration is possible at the discretion of the examiner) 15. Female with an endometrial thickness greater than 5mm by vaginal sonogram. 16. Have participated or planned to participate in other clinical trials within the past month 17. Women using thyroid hormone preparations, clonidine, anticoagulants or antithrombotic agents (Warfarin, Clopidogrel, etc.) within 3 months 18. Those taking or administering a therapeutic agent for osteoporosis, such as a bisphosphonate preparation 19. Those who investigator judges inappropriate to participate in this study. The reason for this consideration should be recorded in the source document.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The changing rate(value) of the Modified KIs total/individual item scores from the baseline to 4 weeks, 8 weeks and 12 weeks. 2. The changing rate of the Menopause Rating Scale (MRS) from the baseline to 4 weeks, 8 weeks and 12 weeks. 3. The changing rate of the Vaginal Maturation Index (VMI) after 12 weeks from the baseline 4. The changing rate of the Vaginal pH after 12 weeks from the baseline. Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Clinically significant change from baseline to EOT in the Laboratory tests and vital signs 2.The changing rate of Estradiol (E2) after 12 weeks from the baseline. 3.The changing rate of FSH after 12 weeks from the baseline 4.The changing rate of Luteinizing hormone (LH) after 12 weeks from the baseline 5.The changing rate of Endometrial thickness after 12 weeks from the baseline 6.Occurrence of adverse reactions or serious adverse events throughout the study period. Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactSubham Dutta
Syncorp Health Pvt. Ltd
Outcome results
None listed