Effect of Dangguijakyaksan on climacteric syndrome: a randomized, double-blind, placebo-controlled pilot trial

Korea Institute of Oriental Medicine0 个研究点目标入组 34 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•(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

发起方