A clinical study of the effects of the three licensed drugs alfuzosin, tamsulosin and silodosin in patients with benign prostatic hyperplasia, a disease predominantly causing urinary problems in aging men.

A comparative study of efficacy and tolerability of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/07/003805

Enrollment

Registered

2013-07-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Benign Prostatic hyperplasia

Interventions

Intervention1: Silodosin: 8mg OD for 3 months, oral administration. Control Intervention1: Alfuzosin: 10mg OD for 3 months, oral administration. Control Intervention2: Tamsulosin: 0.4mg OD for 3 month

Eligibility

Inclusion criteria

Inclusion criteria: Male subjects more than or equal to 45 years with BPH and associated LUTS; IPSS more than or equal to 8. QLS more than or equal to 3. Qmax less than 15ml but more than 4ml with a voided volume of more than 100ml. willingness to give written informed consent and comply with the study procedure, and available for regular follow up.

Exclusion criteria

Exclusion criteria: Patients already on 5 alpha reductase inhibitors. Severe hepatic or renal insufficiency. Patients concomitantly receiving strong CYP3A4 inhibitors. UTI. Urethral stricture. Neurogenic bladder. PSA more than or equal to 5ng/ml. History of urethral or prostatic operation. Likely to need catheterization within next 3 months. Hypotension or severe untreated hypertension. History of esophageal or intestinal obstruction. Patients receiving drugs that may interfere with the response to study medications within previous 6 months like verapamil, androgens, anti-androgens, diuretics, cholinergics, anti-cholinergics and phytotherapy. History of alcohol or drug abuse. Currently suffering from serious disease or malignancy. Significant psychiatric problems. Patients at increased risk of QTc prolongation.

Design outcomes

Primary

Measure	Time frame
Change in total INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS) from baseline.Timepoint: 2, 4, 8 and 12 weeks	—

Secondary

Measure	Time frame
Change in peak urinary flow rate (Qmax) and evaluation of subjective symptoms namely IPSS voiding and storage scores and quality of life (QOL) score compared to baseline.Timepoint: 2, 4, 8 and 12 weeks.	—

Countries

India

Contacts

Public ContactDr Manjunatha R

Kempegowda Institute Of Medical Sciences.

drpundarikahp@gmail.com8951155519

Outcome results

None listed

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