None listed
Conditions
Interventions
Others(Health functional food) : This study employs a parallel-group design, with participants assigned to either the test group or the placebo group. Both groups will take three capsules of a health
Sponsors
Chungnam National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Male adults aged between 45 and 75 years (inclusive). 2) Individuals exhibiting symptoms of late-onset hypogonadism, meeting all of the following criteria: - A total score of 27 or higher on the Aging Males' Symptoms (AMS) questionnaire. - A “Yes” response to item 1 or 7, or a “Yes” response to at least three items among the remaining eight items on the ADAM (Androgen Deficiency in Aging Males) questionnaire. - A total serum testosterone level of 8.59 ng/mL or lower. 3) Individuals deemed eligible based on results from clinical laboratory tests, including hematology, blood chemistry, and urinalysis. 4) Individuals who have received a detailed explanation of the study, fully understood its content, voluntarily agreed to participate, and signed the informed consent form with a commitment to comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1) Individuals with clinically significant diseases involving the hepatobiliary, renal, central or peripheral nervous, respiratory, hematologic/oncologic, cardiovascular, urologic, musculoskeletal, immune, otorhinolaryngologic, psychiatric, or particularly endocrine systems (e.g., diabetes). 2) Individuals who have consumed or are currently consuming health functional foods that may affect menopausal symptoms (e.g., red ginseng, ginseng) within 2 weeks prior to the first dose. 3) Individuals with the following abnormal findings in laboratory tests: - Creatinine > 2 times the upper limit of the normal range (ULN) of the study site - AST (GOT) > 3 × ULN - ALT (GPT) > 3 × ULN - Serum prostate-specific antigen (PSA) = 4.0 ng/mL 4) Individuals with vital signs measured in a seated position that fall into any of the following ranges: Systolic blood pressure = 150 mmHg or < 95 mmHg and Diastolic blood pressure = 100 mmHg or < 50 mmHg 5) Individuals with a history of gastrointestinal diseases that may affect the absorption of the test product (e.g., Crohn’s disease, ulcers, acute or chronic pancreatitis) or gastrointestinal surgeries (excluding simple appendectomy or hernia repair). 6) Individuals who have participated in another clinical trial within 3 months prior to this study or who plan to participate in another clinical trial during this study period. 7) Individuals who donated whole blood within 2 months or component blood within 1 month prior to the first dose, or who received a blood transfusion within 1 month prior to the first dose. 8) Individuals who consume alcohol excessively on a regular basis (more than 21 units per week; 1 unit = 10 g of pure alcohol). 9) Individuals with a clinically significant history of hypersensitivity to medications, herbal preparations, or health functional foods. 10) Individuals currently taking testosterone or anti-androgen medications. 11) Individuals who have used erectile dysfunction treatments such as Viagra?, Levitra?, Cialis?, Zydena, Mvix, PDE-5 inhibitors, intracavernosal injections, or other related therapies within 2 weeks prior to the first dose. 12) Individuals deemed unsuitable for study participation by the investigator based on clinical laboratory results or other relevant reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aging Males' Symptoms (AMS) Questionnaire;Self-Diagnostic Checklist for Androgen Deficiency in the Aging Male (ADAM);Total testosterone;Free testosterone;Sex hormone binding globulin;Total cholesterol;Triglyceride;LDL-cholesterol;HDL-cholesterol | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;Clinical laboratory;Vital sign | — |
Countries
Korea, Republic of
Contacts
Public ContactPark Yechan
Chungnam National University Hospital
Outcome results
None listed