A Clinical Trial for Efficacy and Safety of PSE on prostate gland health
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0004316
- Lead Sponsor
- Chung-Ang Univerisity Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 100
1) Men over 40 and under 75
2) A person whose IPSS (International Prostate Symptom Score) is in the range of 8 ~ 19
3) A person who agrees to participate in this human body test and writes informed consent before the human body test begins.
1) Those who are currently being treated for clinically significant acute or chronic cardiocerebrovascular system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal disorders, mental, infectious and blood and tumor diseases Considering the condition of the subject, the tester can participate in the test, and a simple urinary tract infection can participate after 2 weeks of treatment).
2) Person whose maximum urination rate is less than 5 ml / sec
3) Those whose residual urine content is more than 150ml
4) Those who have undergone genitourinary surgery, including prostate surgery, or other invasive procedures for the treatment of the prostate gland (urethral acupuncture surgery, prostate laser treatment, etc.)
5) Prostate volume 40g or more
6) Those who have been diagnosed with prostate cancer
7) Patients with uncontrolled hypertension (more than 160 / 100mmHg, measurement standard after 10 minutes of test subject stability)
8) Uncontrolled diabetic patients (fasting blood glucose above 180 mg / dl or within 3 months of starting or changing medications due to diabetes)
9) those with thyroid disease
10) Creatinine is more than twice the normal upper limit of the test laboratory
11) Person whose AST (GOT) or ALT (GPT) is 3 times higher than normal upper limit
12) Those who have taken prostatic hypertrophy drugs and dietary supplements within 4 weeks of the start of the test
13) Participants in other clinical trials within 3 months prior to this human trial or plan to participate in other clinical trials during this human trial.
14) Those who are sensitive or allergic to peanut-related foods
15) A person who cannot perform ultrasound examination due to anal disease
16) A person who judges that it is inappropriate for this human application test
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IPSS(International Prostate Symptom Score)
- Secondary Outcome Measures
Name Time Method Testosterone, DHEA-S(Dehydroepiandrosterone sulfate),IGF-1(Insulin-like growth factor 1 ), Estradiol;hs-CRP(high-sensitivity C-reactive protein), IL-6, IL-1b, TNF-a(tumor necrosis factor-alpha), urine NGF(urine nerve growth factor), urine PGE(urine prostaglandin E), urine ATP(Urine Adenosine triphosphate );OABSS(overactive bladder symptom score), NIH-CPSI(National Institute of Health-Chronic Prostatis Symptom Index), AMS(Aging Males' Symptom), ADAM(Androgen Deficiency in Aging Male);Uroflowmetry, Residual Urine;Blood Pressure, Body weight, Waist circumference