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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004585

Enrollment

Registered

2019-12-24

Start date

2020-03-05

Completion date

Unknown

Last updated

2022-10-24

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 : 12-week intake of CKDHC-P29 or placebo. (Randomized, double-blind, placebo-controlled human study)

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Adverse event	—

Countries

Korea, Republic of

Contacts

Public Contactkoh hee

Seoul Metropolitan Government Seoul National University Boramae Medical Center

kohg64@naver.com+82-2-870-3842

Outcome results