Effect of Dangguijakyaksan on climacteric syndrome: a randomized, double-blind, placebo-controlled pilot trial
- Conditions
- Not Applicable
- Registration Number
- KCT0002387
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 34
(1) 45-60 years
(2) Menopausal and female climacteric statesd(menopause includes both natural menopause and induced menopause)
(3) Menopause rating scale (MRS) score of 9 or more
(4) Those who blood-deficiency survey score more than 30 points
(5) A person who has received sufficient explanation of the clinical trial and agrees to participate and signs the consent form
(1) A person who received hormone replacement therapy within 3 months of screening visit
(2) A person who received oriental-medicine treatment for the purpose of improving symptoms of menopausal symptoms within 4 weeks of screening visit
(3) A person who took health functional food or medicines for the purpose of improving symptoms of menopausal symptoms within 4 weeks of screening visit
(4) A person who has severe mental illnesses such as depression and anxiety disorder, or who is currently taking psychotropic drugs such as antidepressants
(5) A person who has uncontrolled thyroid disease (those who are considered to be able to participate in this trial by the tester can participate)
(6) A person whose AST, ALT, ALP, and GGT exceed 1.5 times the normal upper limit
(7) A person whose BUN(Blood urea nitrogen), creatinine 1.5 times the normal upper limit
(8) A person who is currently receiving transfusion or erythropoietin treatment for severe anemia
(9) A menopausal women with unexplained vaginal bleeding
(10) A person with with lactose intolerance
(11) A person who is currently participating in other clinical trials
(12) If the other clinical trial officer judges that it is inappropriate
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Menopause Rating Scale(MRS)
- Secondary Outcome Measures
Name Time Method Korean Version of World Health Organization Quality of Life-BREF, WHOQOL-BREF;Blood-deficiency survey;Follicle Stimulating Hormone(FSH);Estradiol(E2);lean body mass