A human study to evaluate the efficacy and safety of CKDHC-P29 in men with lower urinary tract symptoms

Not Applicable

Completed

• Conditions: Diseases of the genitourinary system

• Registration Number: KCT0004585
• Lead Sponsor: Seoul Metropolitan Government Seoul National University Boramae Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-01-07
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

1) A men who agreed to participate in this study and signed a written informed consent
2) A men aged from 40 to under 80
3) A men with lower urinary tract symptoms of mild to moderate lower urinary tract symptoms (IPSS of 3-19)

Exclusion Criteria

1) A men with prostate volume = 40mL
2) A men with serum (PSA; prostate specific antigen) level =4 ng/mL
3) A men with peak flow rate < 5mL/s or = 15mL/s
4) A men with post-void residual urine = 100mL
5) A men who takes 5aRI, a-blocker, anticholinergics, beta-3 adrenergic agonist
6) A men who takes a saw-palmetto derived supplements within 1 month of first visit
7) A men with prostatitis, urinary tract infection, acute urinary retention, neurogenic bladder, prostate cancer or bladder cancer, etc.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), uroflowmetry;Prostate volume, serum PSA, testosterone;Vital sign;Clinical laboratory test(blood, urine)

Secondary Outcome Measures

Name	Time	Method
Adverse event