None listed
Conditions
Interventions
Others(Functional food) : Oral intake of 500 mg of the Duchong Wooseul extraction mixture (KGC08EA) or placebo tablets once a day (within 30 minutes after breakfast), one tablet once, for 8 weeks.
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Men over 40 years of age 2) Subjects with a total testosterone value of less than 3.5 ng/mL or male menopausal symptom survey (AMS) score of 27 or higher 3) Subjects who has signed the consent form after being briefed on this study
Exclusion criteria
Exclusion criteria: 1) For the purpose of treating symptoms related to men's menopause, people who have taken phosphodiesterase-5 inhibitors, androgen agent, testosterone replacement therapy, statins, fibrates, niacin, steroids, fish oil, anti-obesity treatment, ezetimibe, omega-3 fatty acids, bile acid sequesters, fiber-based laxatives phytosterol margarines, and erectile dysfunction treatments 2) People who has taken diuretics, beta blockers, anticoagulants, or antiplatelet drugs 3) People with a history of hypertension, coronary artery disease, myocardial infarction, angina, heart failure, ischemic heart disease, arrhythmia, cerebral infarction, cerebral hemorrhage, stroke, diabetes, or thyroid disease 4) People with psychogenic menopausal disorder 5) People whose liver function test (AST, ALT, Total bilirubin, Alkaline Phosphatase) value is 2.5 times higher than the normal value 6) People who has a history of renal failure or has a renal function test (creatinine) that is more than 30% higher than the normal value 7) People with prostate specific antigen (PSA) = 4.0 ng/mL 8) People with Hepatitis B Test Positive 9) People with body mass index (BMI) = 35 kg/m2 10) People with a history of alcoholism or substance abuse 11) People with a history of cancer 12) People who has a hypersensitivity to test products 13) People who is at risk of serious drug interaction due to a concomitant drug 14) People who is medically and mentally prohibited from taking investigation drugs 15) People who is legally unable to participate in clinical trials 16) People who participates in another study within six months before the study 17) People who is likely to have an uncooperative attitude in this study or a person who is judged by the researcher to be unable to proceed with the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASM survey | — |
Secondary
| Measure | Time frame |
|---|---|
| ADAM survey, IIEF survey;Hormone biomarkers [total testosterone, free testosterone, sex hormone-bound globulin, insulin like growth factor-1], lipid biomarkers [total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides], body composition [skeletal muscle mass, body fat mass, muscle mass, abdominal fat percentage, body fat volume (visceral fat area, subcutaneous fat area, total fat area)] ;Vital signs, physical examination and measurement, clinical examination, adverse drug reactions, drug use history | — |
Countries
Korea, Republic of
Contacts
Public ContactHak Chul Jang
Seoul National University Bundang Hospital
Outcome results
None listed