Menopausal symptoms Menopause related quality of life Number of hot flushes per day Global patient satisfaction Adverse event Liver function test changes black cohosh menopausal symptoms hot flushes MENQOL Kupperman index Liver function satisfaction
Conditions
Interventions
Black cohosh extract 80 mg daily,Matching placebo
Active Comparator Drug,Placebo Comparator Drug
Black cohosh,Placebo
Sponsors
Cerebos Research Award 2013
Eligibility
Sex/Gender
Female
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Age at least 40 years Peri- or post menopause Moderate to severe menopausal symptoms (KI at least 20)
Exclusion criteria
Exclusion criteria: Use hormonal treatment or other treatments within 4 weeks Use atorvastatin, azathioprine or cyclosporin within 4 weeks BMI at least 30 kg/m2 Allergic to drug or components Liver disease or abnormal liver function test Psychiatric disease Alcoholic or drug abuse Vegetarian
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Kupperman Index 12 weeks Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Menopause specific quality of lilfe 12 weeks Score,Daily hot flushes frequency 12 weeks times,Liver function test 12 weeks Serum measurement,Global satisfaction 12 weeks score,Adverse events 12 weeks events | — |
Countries
Thailand
Contacts
Public ContactPatsama Vichinsartvichai
Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospitall, Navamindradhiraj Univ
Outcome results
None listed