CTRI/2024/06/068991
Not yet recruiting
未知
A Prospective Interventional Open label Single centre Single arm Study to Evaluate the Efficacy and Safety of ProPlus Capsules in Subject suffering with Benign Prostatic Hyperplasia (BPH) - NI
M/s Synthite Industries Private Limited0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- M/s Synthite Industries Private Limited
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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