Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: Ural-BPH Capsule: One Ural-BPH Capsule twice a
day, 15 mins before meals for
16 weeks.
Control Intervention1: Tamsulosin Hydrochloride: One Tamsulosin Hydrochloride
Modified Release Cap
Sponsors
Vasu Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male participants aged between 40 to 80 years diagnosed with symptomatic BPH and coexisting overactive bladder symptoms (OABS), with an IPSS greater than 8, who are treatment-naive and do not wish to undergo surgery;2.Symptomatic participants of BPH (determined by IPSS/focused urological exam/Investigations) associated with any one or more of the following overactive bladder symptoms like; micturition frequency of greater than 8 per 24 hrs, nocturia episodes of greater than 2 per 24 hrs., urgency episodes of greater than 1 per 24 hrs with or without urge incontinence;3.Participants should be willing and able to complete a 4-day voiding diary (before each visit i.e., on baseline, week 2, week 4, 8, 12 and 16) and questionnaires.
Exclusion criteria
Exclusion criteria: 1.Age below 40 and above 80 years at the time of screening; 2.Participant not willing for consent for inclusion in the above study and those who cannot comply with the study protocol due to concomitant CVA, CRF, vesical stones, untreated UTI, diabetic neuropathy, uncontrolled hypertension (BP greater than 180/100), neurological disease etc.; 3.Participants of BPH with absolute indications for surgery; 4.Participants with contraindication, hypersensitivity and allergic reaction to components of investigational product and or tamsulosin hydrochloride; 5.Participants with prior history of prostatic/urethral surgery, acute or chronic prostatitis, known prostate cancer, suspected neurogenic bladder, urethral stricture and priapism; 6.Any other clinical condition which may jeopardize the study outcome or participant health in any way as per discretion of investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in uroflowmetry parameters at baseline and end of the study a)Q max (Peak flow rate) by uroflowmetry b)Percentage of participants with a 3 mL per s increase in Qmax c)Changes in average flow rate (AFR) d)Changes in the post-void residue (PVR) 2.Changes in symptomatic parameters at screening, week 2, 4,8,12 and 16. a)Changes in urinary symptoms using the American Urological Association (AUA) symptom scoring b)Changes in episodes of acute urinary retention (AUR) c)Change in International prostate symptom score (IPSS) 3.Change in Prostate Specific Antigen (PSA) Level (for 20 participants only) at baseline and end of the study. 4.Changes in day-time and night-time trends in urinary frequency at baseline, week 2, 4,8,12 and 16. 5.Change in overall BPH specific quality of life scale questionnaire scores at baseline and end of the study.Timepoint: screening, baseline, week 2, 4,8,12 and 16(end of the study) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in Sexual Function Inventory Score (SFIS) at baseline, weeks 4,8,12 and 16. 2.Changes in the number of responders to positive orthostatic tests between groups at baseline, weeks 4,8,12 and 16. The working definition of positive orthostatic test- (a) Decrease in SBP of greater than or equal to 20mmHg on standing compared with supine SBP (b) Decrease in DBP of greater than or equal to 10mmHg on standing compared with supine DBP or a DBP of less than 65 mmHg on standing (c) Increase in PR of greater than 20 bpm on standing or a standing PR of greater than or equal to 100 bpm (d) Presence of clinical symptoms on standing (faintness, light-headedness, dizziness, spinning, sensation, vertigo or nausea) 3.Changes in hematological and biochemical parameters such as CBC, LFT, RFT, and lipid profile at baseline and end of the study. Timepoint: screening, baseline, week 2, 4,8,12 and 16(end of the study) | — |
Countries
India
Contacts
Public ContactDr Hardik Soni
Vasu Healthcare Pvt Ltd
Outcome results
None listed