None listed
Conditions
Interventions
Dietary Supplement : 1) Experimental product
- Active Ingredient: Salvia miltiorrhiza Ethanol Extract Powder (SAGX)
- Dosage and Administration: 2 capsules once daily with water after breakfast.
-
Sponsors
Gangnam Guard Urology Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Male subjects between the ages of 40 and 80 (inclusive). 2) Patients with mild to moderate lower urinary tract symptoms (LUTS); however, this is limited to patients whose standard medical treatment is difficult due to side effects, or those the Principal Investigator determines are suitable for observation based on clinical results such as ultrasound, digital rectal examination, uroflowmetry, and post-void residual volume measurement. 3) Subjects who voluntarily agree to participate in the study and provide their signature on the Informed Consent Form (ICF) prior to the initiation of the study.
Exclusion criteria
Exclusion criteria: 1) Individuals currently receiving treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal/urinary, neurological, musculoskeletal, psychiatric, or infectious diseases, or malignant tumors (However, participation may be permitted at the discretion of the Principal Investigator considering the subject's condition). 2) Individuals with a serum Prostate Specific Antigen (PSA) level of 4.0 ng/mL or higher (However, those with confirmed test results within 3 months of Visit 1 indicating no malignancy are eligible for enrollment). 3) Individuals diagnosed within 4 weeks of Visit 1 with urinary tract stones, urethral stricture, bladder neck contracture, lower urinary tract inflammation (bladder, urethra), urinary tract tuberculosis, prostatitis, urinary tract infection, acute urinary retention, or neurogenic bladder disease. 4) Individuals diagnosed with prostate cancer or bladder cancer. 5) Individuals who have undergone prostate-related surgery or other invasive procedures. 6) Individuals who have undergone surgery that could affect lower urinary tract symptoms, such as urethrotomy or bladder neck incision. 7) Patients with uncontrolled hypertension (defined as systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, measured after 10 minutes of rest). 8) Patients with uncontrolled diabetes (defined as fasting blood glucose of 180 mg/dL or higher or having started a new medication for diabetes within the last 3 months). 9) Individuals with thyroid disease. 10) Individuals currently taking medications for Benign Prostatic Hyperplasia (BPH)—such as 5-alpha reductase inhibitors, alpha-blockers, anticholinergics, or antidiuretic hormones—or health functional foods related to prostate health (However, those on a stable dose of BPH medication for at least 4 weeks with no planned dose changes during the study may be enrolled at the discretion of the Principal Investigator). 11) Individuals whose AST (GOT) or ALT (GPT) levels are more than 3 times the upper limit of normal (40 IU/L) at the study site. 12) Individuals with hemorrhagic diseases or anemia, or those whose Activated Partial Thromboplastin Time (APTT) falls outside the normal range. 13) Individuals currently taking medications that affect blood coagulation (e.g., aspirin, anticoagulants, etc.). 14) Individuals who have participated in another interventional clinical trial (including human application tests) within 3 months of Visit 1, or who plan to participate in another interventional clinical trial during this study. 15) Individuals with a sensitivity or allergy to the ingredients of the study products. 16) Individuals deemed unsuitable for participation in this study by the investigator. 17) Individuals who are employees of the clinical trial site (hospital).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score, IPSS;International Index of Erectile Function, IIEF | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactEun Young Kim
Gangnam Guard Urology Clinic
Outcome results
None listed