A clinical Trial in patients suffering from dysurea associated with benign prostatic hyperplasia. Clinical trial is to study efficacy, safety and tolerability of Silodosin Capsules 4 mg in comparison to Urief Capsules (reference product).

A comparative, single blind, parallel group, non-crossover, multi-centric trial of Silodosin Capsules 4 mg, with Urief Capsules, in-patients suffering from dysurea associated with benign prostatic hyperplasia.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000806

Enrollment

200

Registered

2009-10-30

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: N400- Benign prostatic hyperplasia without lower urinary tract symptoms Health Condition 2: null- Dysurea associated with benign prostatic hyperplasia

Interventions

Intervention1: Silodosin Cpaules 4 mg: Twice daily for 12 weeks Control Intervention1: Urief Capsules: Twice daily for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male patients between 40 and 75 years of age 2. Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 3. Patient with signs and symptoms of Dysurea Associated with benign prostatic hyperplasia, diagnosed clinically.

Exclusion criteria

Exclusion criteria: 1. Patients <40 & > 75 years. 2. Patients with hypersensitivity to the drug. 3. Concomitant illness 4. Patients who have participated in a drug study in the past 3 months. 5. Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits 6. Use of enzyme-modifying drugs within 30 days prior to day 1 of this study. 7. HIV and Australian Antigen positive subjects. 8. Significant history or presence of glaucoma, cardiovascular or hematological disease. 9. Any condition which are likely to hinder the compliance with the protocol.

Design outcomes

Primary

Measure	Time frame
A comparative evaluation of efficacy of Silodosin Capsules 4 mg, with Urief Capsules, in-patients suffering from dysurea associated with benign prostatic hyperplasia. The efficacy parameters will primarily focus on improvement in the clinical signs & symptoms like Blood in the urine, Dribbling after voiding, Frequent urination, Hesitant, interrupted, or weak urine stream and Recurrent, sudden, urgent need to urinate. Timepoint: Day 0, 1 week,2 week, 4 week,6 week, 8 week and 12 week.	—

Measure

Time frame

A comparative evaluation of efficacy of Silodosin Capsules 4 mg, with Urief Capsules, in-patients suffering from dysurea associated with benign prostatic hyperplasia. The efficacy parameters will primarily focus on improvement in the clinical signs & symptoms like Blood in the urine, Dribbling after voiding, Frequent urination, Hesitant, interrupted, or weak urine stream and Recurrent, sudden, urgent need to urinate. Timepoint: Day 0, 1 week,2 week, 4 week,6 week, 8 week and 12 week.

—

Secondary

Measure	Time frame
A comparative evaluation of safety & tolerability of Silodosin Capsules 4 mg, with Urief Capsules, in-patients suffering from dysurea associated with benign prostatic hyperplasia.Timepoint: Day 0, 1 week, 2 week, 4 week,6 week, 8 week and 12 week.	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shaileshs@ajantapharma.com022-66062112

Outcome results

None listed

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