The efficacy and safety of HX109, a tablet containing Taraxacum officinale Weber and other extracts in men with mild to moderate lower urinary tract symptoms: a 12-week randomized, double-blind, placebo-controlled trial

We conducted this randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of HX109, a tablet containing Taraxacum officinale Weber and other extracts, for improving lower urinary tract symptoms in men with mild to moderate lower urinary tract symptoms.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003161

Enrollment

Registered

2018-09-05

Start date

2018-08-09

Completion date

Unknown

Last updated

2024-03-04

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 : HX109, a tablet containing Taraxacum officinale Weber and other extracts

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 40-80 3) A men with lower urinary tract symptoms of mild to moderate lower urinary tract symptoms (I-PSS of 1-19) 4) A men who could comply with the requirements of the current study

Exclusion criteria

Exclusion criteria: 1) A men with prostate volume = 30mL 2) A men with serum (PSA; prostate specific antigen) level =4 ng/mL 3) A men with peak flow rate = 10mL/s 4) A men with post-void residual urine = 50mL 5) A men who takes 5aRI, a-blocker, anticholinergics 6) A men who takes a saw-palmetto derived supplements within 1 month of his first visit 7) A men with prostatitis, urinary tract infection, acute urinary retention, neurogenc bladder 8) A men with prostate cancer or bladder cancer

Design outcomes

Primary

Measure	Time frame
Changes in total International Prostate Symptom Score (I-PSS);Changes in total Overactive Bladder Symptom Score (OABSS)	—

Secondary

Measure	Time frame
The frequency and severity of adverse reaction	—

Countries

Korea, Republic of

Contacts

Public Contactji koh

Seoul Metropolitan Government Seoul National University Boramae Medical Center

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

Outcome results