None listed
Conditions
Interventions
Others(health functional food) : Subjects are randomly assigned to either the test group or the control group according to the registered order. Subjects take investigational product or placebo for 8
Sponsors
Holistic Bio
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Men over 40 years of age complaining of menopausal symptoms 2) Those who answered “yes” to Question 1 (“Is there a decrease in libido?”) or Question 7 (“Is there a decrease in erection?”) on the Male Menopausal Questionnaire (ADAM) 3) A person who consented to participate in this clinical trial and signed a Informed consent form before the trail began.
Exclusion criteria
Exclusion criteria: 1) Those who have used hormones such as male hormones or similar hormones (plant extracts, etc.) within 1 month of screening 2) Those who have used erectile dysfunction treatment (PDE5 inhibitor) within 1 month of screening 3) Those with a blood PSA (Prostate Specific Antigen) greater than 4 ng/mL 4) Those diagnosed with prostate cancer 5) Body Mass Index 40kg/m2 or more 6) Those who had a history of myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage, angina within 6 months of screening 7) Persons with severe mental illness such as depression, bipolar emotional disorder, schizophrenia, or currently taking psychotropic drugs such as antidepressants 8) Those with a history of endocrine diseases that may affect weight, such as hypothyroidism and Cushing's syndrome (those who are judged to be able to participate in this clinical trial by the Investigator can participate) 9) Uncontrolled hypertension persons (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, measurement criteria after 10 minutes of stability in human subjects) 10) Those who have used insulin or hypoglycemic agents within 3 months of screening 11) Those whose AST(GOT) or ALT(GPT) is more than 3 times the normal upper limit of the study institution 12) Those whose Creatinine is more than twice the normal upper limit of the study institution 13) Those who took appetite suppressants, appetite relievers, oral steroids, and thyroid hormones within 3 months of screening 14) Those with psychogenic menopausal disorder 15) Those with a history of alcoholism or substance abuse 16) Persons who are sensitive or allergic to investigational product for this clinical trial 17) Those who participated in other clinical trials within 1 months of Visit 1 or plan to participate in other clinical trials after the start of this clinical trial. 18) Those who have taken menopausal medicines or health functional foods within 1 month of screening 19) A person who determines that the Investigator is inappropriate for clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of ADAM(Androgen Deficiency in Aging Male) | — |
Secondary
| Measure | Time frame |
|---|---|
| change of ADAM(Androgen Deficiency in Aging Male)'s Individual question;Total testosterone, Free testosterone;SHBG(Sex Hormone Binding Globulin), Albumin;Total Cholesterol, Triglyceride, HDL-Cholesterol, LDL-Cholesterol;total score of AMS(Aging Male’s symptom);total score of IPSS(International Prostate Symptom Score);total score and change of IIEF(International Index of Erectile Function)'s Individual question;LH(Luteinizing hormone);FSH(Follicle Stimulating Hormone);DHEA-S(Dehydroepiandrosterone Sulfate);IGF-1(Insulin-like growth factor-1);Estradiol;FBS(fasting blood sugar);Insulin;HOMA-IR(Homeostatic Model Assessment for Insulin Resistance);QUICKI(quantitative insulin sensitivity check index);HOMA-ß(Homeostatic model assessment of ß-cell function);Blood pressure;waist circumference;hip circumference;weight;adverse event;Clinical pathology examination;PSA(Prostate Specific Antigen) | — |
Countries
Korea, Republic of
Contacts
Public ContactJinwook Kim
Chung-Ang Univerisity Hospital
Outcome results
None listed