Health Condition 1: null- bph
Conditions
Interventions
None listed
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. An International Prostatic Symptom Score (IPSS) of >8, 2. maximum urinary flow rate (Qmax) >15 mL/second with minimum voided volume of >125 mL at screening, and 3. willing and able to give written informed consent and comply with study procedures 4. PSA less than 4 ng/ml
Exclusion criteria
Exclusion criteria: 1. contraindications to investigational drugs including patients with known allergies/allergy to drugs under study, 2. history of syncope, and orthostatic hypotension 3. bladder outlet obstruction due to cancer, calculi or stricture, 4. previous transurethral resection of the prostate, 5. any neurological disorders affecting storage and voiding functions 6. an episode of acute urinary retention within 4 weeks of study initiation, 7. poorly controlled diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 1 MONTH AND 3 months of the treatment Primary efficacy end points will include - subjective (IPSS, IPSS QoL index) and objective (Qmax and PVR) changes from baseline. Safety assessment will include laboratory tests (hematology, clinical biochemistry, and urinalysis) and patientâ??s reporting of adverse event.Timepoint: At 1 MONTH AND 3 months of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| correlate improvement in ipss scotre with clinical improvementTimepoint: At 1 MONTH AND 3 months of the treatment | — |
Countries
India
Contacts
Public ContactDR YOGESH TANEJA
SRI SATHYA SAI UNIVERSITY OF HIGHER LEARNING
Outcome results
None listed