To evaluate the safety and efficacy of herbal / nutraceutical tablet plus standard of care when compared with only standard of care in patients with benign prostatic hyperplasia.
- Conditions
- Health Condition 1: N400- Benign prostatic hyperplasia without lower urinary tract symptoms
- Registration Number
- CTRI/2022/05/042513
- Lead Sponsor
- Arogyaseva Medical Academy of India AMAI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 151
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 < 300 ml as assessed by
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)
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 <90/60 mm
Hg) / uncontrolled hypertension (=170/100 mm Hg)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Total International Prostate Symptom Score (IPSS) from <br/ ><br>baseline to EOTTimepoint: baseline to Day 90
- Secondary Outcome Measures
Name Time Method Change in IPSS storage (Irritative) sub score from baseline to EOT <br/ ><br>• Change in IPSS voiding (Obstructive) sub score from baseline to <br/ ><br>EOT <br/ ><br>• Change in IPSS quality of life (QOL) Index from baseline to EOT <br/ ><br>• Change in Qmax from baseline to EOT <br/ ><br>• Change in PVR volume from baseline to EOT <br/ ><br>• Change in IIEF-EF (question 1-5 and 15) score from baseline to EOT <br/ ><br>• Proportion of participants with AE and SAE from the data of <br/ ><br>screening to EOT <br/ ><br>• Proportion of patients having common side effects of alpha <br/ ><br>blockers from baseline to EOT.Timepoint: baseline to Day 90