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A Clinical Trial for Efficacy and Safety of PSE on prostate gland health

Efficacy and Safety of PSE on prostate gland health; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004316
Enrollment
100
Registered
2019-10-15
Start date
2018-12-18
Completion date
Unknown
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : The test group ingested 1 tablet twice a day for 12 weeks with water and 1g / day as a peanut sprout extract. The control group is ingested 1 tablet twice a day for 12 weeks with

Sponsors

Chung-Ang Univerisity Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
IPSS(International Prostate Symptom Score)

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactSuncheol Myung

Chung-Ang Univerisity Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026