Hot flashes Safety Curcuma comosa Hotflashes Safety Menopause Perimenopause Climacteric symptoms
Conditions
Interventions
Hexane extract of Curcuma mosa in the dose 250 mg per tablet,Hexane extract of Curcuma mosa in the dose 500 mg per tablet
Active Comparator Drug,Active Comparator Drug
Crude extract 250 mg per tablei,Crude extract 500 mg per tablet peer
Sponsors
Agricaultural research development agency (Public organization)
Ramathibodi hospital
Eligibility
Sex/Gender
Female
Age
40 Years to 55 Years
Inclusion criteria
Inclusion criteria: Women age 40 55 years with one of the followings 1 Perimenopause with no more than 1 month of menstruation within 3 months 2 Amenorrhea more than 12 months postmenopause 3 After bilateral oophorectomy with or without hysterectomy more than 6 weeks
Exclusion criteria
Exclusion criteria: 1 Use hormone within 3 months before subject recruitment 2 Previous history of myocardial infarction or stroke within 6 months 3 Breast cancer or endometrial cancer within 5 years 4 Active thromoblebitis 5 Endometrial hyperplasia 6 Acute hepatitis 7 Abnormal renal function 8 insulinoma pheochromocytoma carcinoid syndromes leukemia pancreatic tumors autoimmune disorders and mast cell disorders 9 Current usage of tamoxifene raloxifene
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequecy and severity of hot fushes 1 and 4 month Count and rate severity of symptom | — |
Secondary
| Measure | Time frame |
|---|---|
| renal and liver functions 1 and 4 month Blood test i.e. Elisa,Presence of abnormal findings at uterus and organ 1 and 4 month Ultrasond at lower abdoment,Vaginal maturation index 1 and 4 month Counting cells,Vaginal pH 1 and 4 month pH stripping testing | — |
Countries
Thailand
Contacts
Public ContactAreepan Sophonsritsuk
Mahidol University
Outcome results
None listed