A human study to evaluate the efficacy and safety of pollen extract G63® in men with lower urinary tract symptoms

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007869

Enrollment

120

Registered

2022-11-02

Start date

2022-12-20

Completion date

Unknown

Last updated

2024-06-24

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 pollen extract G63® 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 1-19)

Exclusion criteria

Exclusion criteria: 1) A men with prostate volume = 40mL 2) A men with serum PSA level =4 ng/mL 3) A men with peak flow rate < 5mL/s 4) A men with post-void residual urine = 150mL 5) A men who takes 5aRI, PDE-5 inhibitor, a-blocker, anticholinergics, beta-3 adrenergic agonist 6) A men who takes health functional foods which can affect prostate health within 1 month of first visit 7) A men with acute 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),residual urine volume, uroflometry ;NIH-chronic prostatitis symptom index (NIH-CPSI), International index of erectile function-5(IIEF-5), serum PSA	—

Secondary

Measure	Time frame
Vital sign;Clinical laboratory test(blood, urine);Adverse event	—

Countries

Korea, Republic of

Contacts

Public ContactYOUNG HEO

Dankook Univeristy Hospital

hy@dkuh.co.kr+82-41-550-7496

Outcome results