Skip to content

A comparative study on the treatment effect of Hytrin alone or Hytrin/Hinechol combined administration to patients with prostatic hyperplasia with lower urinary tract symptoms (LUTS)

A comparative study on the treatment effect of Hytrin alone or Hytrin/Hinechol combined administration to patients with prostatic hyperplasia with lower urinary tract symptoms (LUTS)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0005736
Enrollment
200
Registered
2021-01-04
Start date
2021-01-25
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

None listed

Interventions

Drug : 1) Hytrin administration group: Orally 1 tablet 5 mg QD for 16 weeks 2) Hytrin / Hinechol combined administration group: Oral use of Hytrin 5mg QD for 16 weeks and Hinechol 25mg 2 tablets BID

Sponsors

Cheongju ST.Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Men over 40 years old 2) Those with a total score of 8 or more in the International Prostate Symptom Score (IPSS) 3) Those who voluntarily decide to participate in this study and consent in writing to the subject's consent

Exclusion criteria

Exclusion criteria: 1) Those with hypersensitivity to Hythrin-based drugs (alpha-blocker) and Heinecol-based drugs (cholinergic drugs) 2) Those with clinically significant circulatory diseases (myocardial infarction, heart failure, angina, deep veins, pacemaker use, orthostatic hypotension, uncontrolled hypotension) 3) Those on hemodialysis 4) Those who show persistent oliguria due to renal function abnormalities 5) Patients with moderate hepatic impairment (Child-Pugh grade B) 6) Those who participated in other interventional clinical trials within 6 months of screening 7) Those who have a history of or present malignant tumors, and who are inadequate to participate in the study as judged by the principal investigator or the investigator. 8) Asthma patients, patients with hyperthyroidism 9) Others who are inadequate to participate in the research as judged by theprincipal investigator or the investigator.

Design outcomes

Primary

MeasureTime frame
International Prostate Symptom Score change

Secondary

MeasureTime frame
Post-void residual urine change;Maximum flow rate change

Countries

Korea, Republic of

Contacts

Public ContactTongwook Kim

Cheongju ST.Mary's Hospital

urotwkim@gmail.com+82-43-219-8237

Outcome results

None listed

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