FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/096957 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Tadalafil Alleviating Clinical Symptoms of Benign prostatic enlargement. 
Scientific Title of Study   Tadalafil add-on therapy in reducing systemic inflammatory markers and alleviating clinical symptoms in patients with symptomatic Benign Prostatic Enlargement: An open-labelled randomized clinical trial. 
Trial Acronym  T-REACT Stands for Tadalafil for Reducing inflammation and Alleviating Clinical Symptoms Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kalandi Barik 
Designation  Assistant Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Urology, 2nd Floor , AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  8309363827  
Fax    
Email  urol_kalandi@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Kalandi Barik 
Designation  Assistant Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Urology, 2nd Floor , AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  8309363827  
Fax    
Email  urol_kalandi@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Kalandi Barik 
Designation  Assistant Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Urology, 2nd Floor , AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  8309363827  
Fax    
Email  urol_kalandi@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Odisha 751019 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Intra mural funded project, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha, India Pincode 751019 
Type of Sponsor  Government medical college 
 
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 Kalandi Barik  AIIMS Bhubaneswar  Department of Urology, 2nd Floor, Room 245, AIIMS Bhubaneswar, Sijua, Patrapada
Khordha
ORISSA 		 8309363827

urol_kalandi@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee AIIMS bhubaneswar  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  Non tadalafil group   Male patients with LUTS who do not receive Tadalafil add on therapy along with alpha blocker with or withut dutasteride Duration 12 months  
Intervention  Tadalafil Group  Male patients with LUTS who receive Tadalafil add on therapy along with alpha Blocker with or without Dutasteride for 12 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Male 
Details  Consented male patients aged 18 years and above who present to Urology OPD with BPE and LUTS 
 
ExclusionCriteria 
Details  Patients not giving informed consent
2. Patients with urethral stricture disease
3. Patients with vesical or ureteric calculi
4. Patients with known hypersensitivity to tadalafil
5. Patients receiving Nitric Oxide supplying agents like Nitroglycerin, Isosorbide dinitrate etc.
6. Patients with unstable angina, heart failure, poorly controlled cardiac arrhythmia and hypertension
7. Patients with history of myocardial infarction within 3 months
8. Patients with history of cerebro-vascular accident within 6 months
9. Child-Pugh class C hepatic dysfunction
10. Chronic Kidney Disease patients with eGFR less than 30 ml per min per 1.73m2
11. Patients with angle closure glaucoma
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the serum IL-6, IL-8, IL-17, IL-18 levels at baseline and at one month follow-up among male BPE patients with LUTS with or without tadalafil add-on therapy.

 		 12 months post initiation of therapy

 
 
Secondary Outcome  
Outcome  TimePoints 
• To compare improvements in IPSS, OABSS and IIEF-5 scores at baseline and at one month follow-up among male BPE patients with LUTS with or without tadalafil add-on therapy.  12 months post initiation of therapy 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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   Phase 3 
Date of First Enrollment (India)   01/12/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary   Open label randomized parallel group clinical trial at AIIMS Bhubaneswar in the Departments of Urology and Biochemistry. Adult men with benign prostatic enlargement and lower urinary tract symptoms will be enrolled after consent. Participants will be randomized by computer using sealed envelopes to two groups. Intervention group: standard therapy with an alpha blocker with or without dutasteride plus tadalafil five milligrams once daily. Control group: standard therapy with an alpha blocker with or without dutasteride without tadalafil. Follow up is one month. Primary outcome is change in serum inflammatory markers interleukin 6, interleukin 8, interleukin 17, and interleukin 18 from baseline to one month. Secondary outcomes are change in symptom scores IPSS, OABSS, IIEF 5 and uroflowmetry measures including Qmax voided volume and post void residual. Adverse events will be actively monitored and managed as per a predefined plan. Sample size is sixty two total with thirty one per arm. Total study duration is twelve months after ethics approval and CTRI registration. Study aim is to test whether tadalafil add on reduces systemic inflammation and improves symptoms in this population. 
Close