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CTRI Number  CTRI/2024/06/069480 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 24/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Herbal]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical study in prostate enlargement. 
Scientific Title of Study   A Comparative, randomized clinical trial to evaluate the efficacy & safety of Ural-BPH Capsule in adult patients with uncomplicated benign prostatic hyperplasia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/005 Version: 1.00; dated 08 May 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sagar Bhalerao 
Designation  Consultant Urologist 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  Fourth-floor OPD 401 314 B Telco Road Chinchwad Pune

Pune
MAHARASHTRA
411033
India 
Phone  9819846896  
Fax  -  
Email  bhaleraosagar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hardik Soni 
Designation  Asst. General Manager (R & D) 
Affiliation  Vasu Healthcare Pvt Ltd 
Address  967 4, GIDC, Opposite ERDA, Makarpura Vadodara

Vadodara
GUJARAT
390010
India 
Phone  9428692240  
Fax  -  
Email  hsoni@vasuresearch.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hardik Soni 
Designation  Asst. General Manager (R & D) 
Affiliation  Vasu Healthcare Pvt Ltd 
Address  967 4, GIDC, Opposite ERDA, Makarpura Vadodara


GUJARAT
390010
India 
Phone  9428692240  
Fax  -  
Email  hsoni@vasuresearch.com  
 
Source of Monetary or Material Support  
Vasu Healthcare Pvt. Ltd. 967 4, GIDC, Opposite ERDA, Makarpura Vadodara, Gujarat, 390010 
 
Primary Sponsor  
Name  Vasu Healthcare Pvt Ltd  
Address  967 4, GIDC, Opposite ERDA, Makarpura Vadodara, Gujarat, 390010 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit Paliwal  Dr. D. Y. Patil College of Ayurved & Research Centre  Sant Tukaram Nagar, Pimpri, Pune – 411018 Maharashtra, India.
Pune
MAHARASHTRA 
8087975264
-
dramitpaliwal@gmail.com 
Dr Sagar Bhalerao  Lokmanya Medical Research Centre and Hospital  Fourth-floor OPD 401 314 B Telco Road Chinchwad Pune
Pune
MAHARASHTRA 
9819846896
-
bhaleraosagar@gmail.com 
Dr Deepakkumar Mane   Sangvi Multispeciality Hospital   Sr. No. 71/1/2/189, City survey No. 2387, Krushna Chowk, Krushna Nagar, New Sangvi, Pune-411027, Maharashtra, India
Pune
MAHARASHTRA 
8237920373
-
drdeepak.sangvihospital@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Dr. DYPCA & RC Institutional Ethics Committee   Approved 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Sangvi Multispecialty Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tamsulosin Hydrochloride  One Tamsulosin Hydrochloride Modified Release Capsule once daily, 30 mins after dinner for 16 weeks. 
Intervention  Ural-BPH Capsule  One Ural-BPH Capsule twice a day, 15 mins before meals for 16 weeks. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  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. 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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. 
screening, baseline, week 2, 4,8,12 and 16(end of the study) 
 
Secondary Outcome  
Outcome  TimePoints 
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.
 
screening, baseline, week 2, 4,8,12 and 16(end of the study) 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "79"
Final Enrollment numbers achieved (India)="79" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   08/07/2024 
Date of Study Completion (India) 06/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

BPH is a prevalent condition among aging males, often associated with bothersome lower urinary tract symptoms and decreased quality of life. Alpha-blockers like Tamsulosin are commonly prescribed to alleviate symptoms by relaxing smooth muscle in the prostate and bladder neck, improving urine flow and reducing lower urinary tract symptoms .

However, while alpha-blockers are effective in managing BPH symptoms, they are associated with adverse effects such as postural hypotension, ejaculatory disorders, and reduced libido, impacting participant compliance and satisfaction. Additionally, they may not address all aspects of BPH, including overactive bladder symptoms, which often coexist with BPH and contribute to the overall burden of the disease.

Given the limitations of existing therapies, there is a need for alternative treatments such as Ural-BPH Capsule, containing a proprietary blend of herbal extracts, presents a promising avenue due to its potential to target multiple aspects of BPH pathophysiology while while maintaining a favorable safety profile by potentially minimizing adverse effects associated with conventional treatments.

By conducting a comparative, randomized clinical trial, this study aims to provide robust evidence regarding the symptomatic relief, urodynamic improvement, and impact on quality of life offered by Ural-BPH Capsule compared to Tamsulosin. Additionally, the trial seeks to assess changes in sexual function, orthostatic tolerance, and safety profiles between the two treatment groups.

The study’s design includes comprehensive assessments encompassing uroflowmetry parameters, urinary symptom scores, PSA(Prostate Specific Antigen) levels, quality of life measures, and safety profiles, thereby offering a holistic evaluation of treatment efficacy and tolerability. Furthermore, the inclusion of hematological and biochemical assessments provides insights into potential systemic effects of the interventions.

Ultimately, the outcomes of this trial will contribute to evidence-based decision-making in the management of BPH, potentially offering a safer and more efficacious alternative to current therapeutic options. By addressing unmet clinical needs and optimizing participant outcomes, this study endeavors to improve the standard of care for individuals suffering from uncomplicated BPH.

 
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