None listed
Conditions
Interventions
Dietary Supplement : The test food (HUN2-575) or the control food (HUN2-575-R) is to be taken orally once daily, two tablets per dose.
Sponsors
Huons
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 and older 2) Individuals with symptoms of urgency and frequency lasting for more than 3 months at Visit 1 3) Individuals with an average of 8 or more voids per day over a 3-day period as recorded in the micturition diary between Visit 1 and Visit 2 4) Individuals with a score of 2 or more for urgency on the Overactive Bladder Symptom Score and a total Overactive Bladder Symptom Score of 3 or more, meeting the diagnostic criteria for overactive bladder 5) Individuals who have agreed to participate in this human application trial before its initiation and have signed a written informed consent form
Exclusion criteria
Exclusion criteria: 1) Individuals currently undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary, renal and urological, neurological, endocrine, psychiatric, infectious diseases, or malignant tumors 2) Individuals with a history of prostate disease or prostate surgery, gynecological surgery, hysterectomy, incontinence-related surgery, or pelvic surgeries such as colon cancer 3) Individuals with physical bladder compression factors such as urinary tract infections (urethritis, cystitis), neurogenic bladder, uterine cancer, or bladder cancer 4) Individuals with kidney stones, urinary stones, bladder stones, tuberculosis, other infectious diseases, or neurological diseases (stroke, Parkinson's disease, etc.) 5) Individuals taking medications for lower urinary tract symptoms (bladder, urethra), cardiac stimulants, diuretics, or cholinergic drugs 6) Individuals who have taken medications for improving urinary function (antimuscarinics, combination agents, tricyclic antidepressants, tamsulosin, etc.) or health supplements (e.g., pumpkin seed extract, composite mixtures, etc.) containing Sagunja or related ingredients within 3 months (90 days) before Visit 1 7) Individuals who have received treatments for improving urinary function (such as voiding training, pelvic floor muscle exercises, etc.) within 1 month (30 days) before Visit 1 8) Heavy smokers (smoking more than 20 cigarettes per day) 9) Individuals who consume alcohol chronically: more than 40 g per day (280 g per week) for men, more than 20 g per day (140 g per week) for women 10) Individuals with a post-void residual volume of 100 mL or more 11) Individuals with AST (GOT) or ALT (GPT) levels more than 3 times the normal upper limit of the testing institution 12) Individuals with a TSH level below 0.1 µIU/mL or above 10 µIU/mL, or those who are taking medication for thyroid disorders 13) Individuals with an eGFR below 60 mL/min/1.73 m² 14) Individuals with uncontrolled diabetes (HbA1c above 7.0%) 15) Individuals with uncontrolled hypertension (systolic blood pressure above 140 mmHg or diastolic blood pressure above 90 mmHg, measured after 10 minutes of rest) 16) Pregnant or breastfeeding individuals, or those planning pregnancy during the trial period 17) Individuals with a history of childbirth within 6 months before Visit 1 18) Individuals who have participated in another interventional clinical trial (including human application trials) within 3 months (90 days) before Visit 1, or those planning to participate in another interventional clinical trial (including human application trials) during the trial period 19) Individuals with hypersensitivity or allergies to the ingredients in the human application trial food (test food or control food) 20) Individuals who are deemed unsuitable by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urination frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Overactive Bladder-Validated 8-question Screener;Overactive Bladder Symptom Score;Post-void residual volume ;Urination flow rate (maximum, average) ;Urine volume, urgency severity, and frequency of incontinence | — |
Countries
Korea, Republic of
Contacts
Public ContactSae Woong Kim
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed