Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: Proplus(Pumpkin seed oil Quercetin Vitamin D3 and Selenium) Nutraceutical product: 01 capsule once in a day after lunch with defined standard of care for 90 Days duration
Control Interv
Sponsors
M/s Synthite Industries Private Limited
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Improvement in Total International Prostate Symptom Score (IPSS) 2 Definition of improvement Reduction in IPSS score of â?¥25%Timepoint: from baseline to End of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Improvement in maximum urinary flow rate (Qmax) & Change in Qmax 2 Evaluation of change in Total IPSS storage(Irritative) score 3 Evaluation of change in Total IPSS voiding (Obstructive)score 4 Evaluation of change in Total IIEF-EF score 5 Reduction in inflammation of prostate area 6 Improvement in Prostate specific antigen (PSA) level 7 Improvement in PVR volume from screening 8 Evaluation of change in Quality of Life (QOL) Index score 9 Reduction in frequent urinationTimepoint: 1 Baseline(Day 0) & EOT (Day 90) 2 baseline to EOT(Day 90) 3 baseline to EOT(Day 90) 4 baseline to EOT(day 90) 5 baseline to EOT (Day 90) 6 baseline to EOT(Day 90) 7 baseline to EOT(day 90) 8 baseline to EOT(Day90) 9 baseline to EOT (Day 90) | — |
Countries
India
Contacts
Public ContactMr Chandu Devanpally
Ardent Clinical Research Services
Outcome results
None listed