To see the Efficacy and Safety of ProPlus Capsules in patients with Benign Prostatic Hyperplasia (BPH)

Not Applicable

• Conditions: Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

• Registration Number: CTRI/2024/06/068991
• Lead Sponsor: M/s Synthite Industries Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 Male Patients of age between 18 years to 65 years both inclusive who are diagnosed case of benign Prostatic Hyperplasia

2 Patients having International Prostate Symptom Score IPSS greater than or equal to 8 moderate to severe BPH at time of enrollment

3 Patients having Qmax between 5 ml per sec and 15ml per sec both included with minimum voided volume of greater than 125 ml at the time of Screening

4 Patients having post voiding residue PVR of less than 300 ml as assessed by Ultrasound at screening

5 Patient is willing to give Informed Consent

Exclusion Criteria

1 Prostate specific antigen (PSA) beyond 4 ng per mL at screening and enrolment

2 Patient with history of neurologic bladder urethral strictures urinary tract infections prostatitis urologic cancer and prostatic surgery

3 Patient with clinically significant bladder outflow obstruction other than BPH (calculi tumour or stricture) as judged by Investigator

4 Clinical evidence of any other bladder or urinary tract conditions which may affect lower urinary tract symptoms at screening

5 Patient undergoing hemodialysis

6 Patient who are planning for cataract or glaucoma surgery

7 Patients with history of cardiovascular disease

including but not limited to

History of Myocardial Infraction within the last 90 days

History of angina

History of congestive cardiac failure

History with uncontrolled arrhythmias hypotension Blood Pressure less than 90 per 60 mm Hg uncontrolled hypertension greater than or equal to 170 per 100 mm Hg

Study & Design

• Study Type: Interventional
• Study Design: Not specified