| 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
|
|
|
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
|
|
|
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. |