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CTRI Number  CTRI/2026/03/106496 [Registered on: 18/03/2026] Trial Registered Prospectively
Last Modified On: 17/03/2026
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Safety And Efficacy of Tamsulosin and Silodosin in Patients of Benign Prostatic Hyperplasia 
Scientific Title of Study   Safety And Efficacy of Tamsulosin and Silodosin in Patients of Benign Prostatic Hyperplasia: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pritkumar Hirani 
Designation  PG resident, Department of Pharmacology 
Affiliation   
Address  6th floor, Department of Pharmacology, Geetanjali Medical College and Hospital, Hirenmagri, Eklingpura, Udaipur

Udaipur
RAJASTHAN
313003
India 
Phone  9427955870  
Fax    
Email  prit.hirani1895@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sangita Gupta 
Designation  Professor, Department of Pharmacology 
Affiliation   
Address  6th floor, Geetanjali Medical College and Hospital, Hirenmagri, Eklingpura, Udaipur

Udaipur
RAJASTHAN
313003
India 
Phone  9829203024  
Fax    
Email  sangitaarungupta57@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sangita Gupta 
Designation  Professor, Department of Pharmacology 
Affiliation   
Address  6th floor, Geetanjali Medical College and Hospital, Hirenmagri, Eklingpura, Udaipur

Udaipur
RAJASTHAN
313003
India 
Phone  9829203024  
Fax    
Email  sangitaarungupta57@gmail.com  
 
Source of Monetary or Material Support  
Geetanjali Medical college and Hospital, Udaipur, Rajasthan, India, 313003 
 
Primary Sponsor  
Name  Dr Pritkumar HIrani 
Address  Hiranmagri Extension, Manwakhera NH-8 Bypass, Near Eklingpura, Chouraha, Udaipur, Rajasthan 313003 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pritkumar Hirani  Outpatient Department of Urology, Geetanjali Medical College and Hospital, Udaipur  Hiranmagri Extension, Manwakhera NH-8 Bypass, Near Eklingpura, Chouraha, Udaipur, Rajasthan 313003
Udaipur
RAJASTHAN 		 09427955870

prit.hirani1895@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N400||Benign prostatic hyperplasia without lower urinary tract symptoms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Silodosin  8 mg capsules orally once daily at bedtime for 8 weeks. 
Intervention  Tamsulosin  0.4 mg capsules orally once daily at bedtime for 8 weeks. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  1. Patients diagnosed with BPH with an age of more than 40 years old come to the outpatient department (OPD),
2. International Prostate Symptom Score (IPSS) score of 8 and above,
3. Maximum flow rate of less than 10 ml/s.
 
 
ExclusionCriteria 
Details  1. Patients with
Neurogenic bladder,
Bladder neck contracture,
Stricture urethra,
Bladder calculi,
Active urinary tract infection,
Prostate cancer,
2. Hemodynamically unstable patients,
3. Patients having an absolute indication for surgery,
4. Allergic to test drugs,
5. Not willing to participate in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in IPSS score, maximum urinary flow rate, and residual urine volume between Group T and Group S.  From baseline to follow-up at 8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Any side effects like dizziness, retrograde ejaculation, postural hypotension, and others reported by patients in both groups.  From baseline to follow-up at 8 weeks  
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prit.hirani1895@gmail.com].

  6. For how long will this data be available start date provided 01-04-2026 and end date provided 31-03-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - no
Brief Summary   This study is a prospective, randomized, open-label, parallel-group study that will be conducted at Geetanjali Medical College and Hospital, Udaipur. It aims to compare the safety and efficacy of tamsulosin (0.4 mg) and silodosin (8 mg) in patients with benign prostatic hyperplasia (BPH). Eligible patients aged above 40 years with an International Prostate Symptom Score (IPSS) 8 or more than 8 and maximum urinary flow rate less than 10 ml/s will be randomly allocated into two groups to receive either tamsulosin or silodosin once daily. Treatment outcomes will be evaluated at baseline and 8 weeks using changes in IPSS, maximum urinary flow rate (Qmax), and post-void residual urine volume (PVR). Safety will be assessed by monitoring adverse effects such as dizziness, postural hypotension, and retrograde ejaculation. The study will aim to determine the comparative effectiveness and safety profile of these two drugs in patients with BPH.
Hypothesis - There is no significant difference in the efficacy and safety between tamsulosin and silodosin in patients with benign prostatic hyperplasia.
 
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