Health Condition 1: N400- Benign prostatic hyperplasia without lower urinary tract symptoms
Conditions
Interventions
None listed
Sponsors
Arogyaseva Medical Academy of India AMAI
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) = 8 (moderate to severe BPH at time of randomization) 3. Patients having Qmax between 5 ml/sec and 15ml/sec (both included) with minimum voided volume of > 125 ml at the time of randomization. 4. Patients having post-voiding residue of Ultrasound at randomization. 5. Patients and/or his signatory guardian/responsible person had understood the Consent in his own language and willing to follow the suggestion through the assessment period. (i.e. follow up intervals, medicine dose and suggested investigation and examination)
Exclusion criteria
Exclusion criteria: 1. Prostate specific antigen (PSA) greater than 4 ng/ml at screening and randomization. 2. Patient with History of neurologic bladder, urethral structures, UTIsymptom, Prostatitis, urologic cancer and prostatic surgery. 3. Patient with clinically significant bladder outflow obstruction other than BPH (calculi, tumor or structure) as judged by PI 4. Patient undergoing haemodialysis 5. Patient who are planning for cataract or glaucoma surgery 6. 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 (BP Hg) / uncontrolled hypertension (=170/100 mm Hg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Total International Prostate Symptom Score (IPSS) from baseline to EOTTimepoint: baseline to Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in IPSS storage (Irritative) sub score from baseline to EOT • Change in IPSS voiding (Obstructive) sub score from baseline to EOT • Change in IPSS quality of life (QOL) Index from baseline to EOT • Change in Qmax from baseline to EOT • Change in PVR volume from baseline to EOT • Change in IIEF-EF (question 1-5 and 15) score from baseline to EOT • Proportion of participants with AE and SAE from the data of screening to EOT • Proportion of patients having common side effects of alpha blockers from baseline to EOT.Timepoint: baseline to Day 90 | — |
Countries
India
Contacts
Public ContactMr C Devanpally
Ardent Clinical Research Services
Outcome results
None listed