| CTRI Number |
CTRI/2020/06/025806 [Registered on: 11/06/2020] Trial Registered Prospectively |
| Last Modified On: |
01/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TAMSULOSIN VERSUS ALFUZOSIN IN THE TREATMENT OF LOWER URINARY TRACT SYMPTOMS |
|
Scientific Title of Study
|
COMPARISION OF EFFECTIVENESS BETWEEN TAMSULOSIN AND ALFUZOSIN IN THE TREATMENT OF LOWER URINARY TRACT SYMPTOMS IN A CASE OF BENIGN PROSTATE HYPERTROPHY: A RANDOMISED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akil Anand Kalathil |
| Designation |
Junior Resident |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
508-Carnation A2, Raheja Gardens, Opposite Khedari Petrol Pump, Wanwadi
Armed Forces Medical College, Pune Cantt, Pune - 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
9160408457 |
| Fax |
|
| Email |
a7anand@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S Tripathy |
| Designation |
Associate Professor |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Armed Forces Medical College, Pune Cantt, Pune - 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
9160408457 |
| Fax |
|
| Email |
dr.stripathy@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akil Anand Kalathil |
| Designation |
Junior Resident |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
508-Carnation A2, Raheja Gardens, Opposite Khedari Petrol Pump, Wanwadi
Armed Forces Medical College, Pune Cantt, Pune - 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
9160408457 |
| Fax |
|
| Email |
a7anand@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College Pune |
|
|
Primary Sponsor
|
| Name |
ARMED FORCES MEDICAL COLLEGE |
| Address |
ARMED FORCES MEDICAL COLLEGE, PUNE, MAHARASHTRA 411041 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akil Anand |
Armed Forces Medical College |
Department of General Surgery
Armed Forces Medical College
Solapur road Wanwadi
Pune 411040
Pune
MAHARASHTRA |
9160408457
a7anand@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
Alfuzosin |
Administration of oral Alfuzosin 10 mg HS (every night) to patients of BPH with LUTS for the duration of trial (6 months) |
| Intervention |
Tamsulosin |
Administration of oral Tamsulosin 0.4 mg HS (every night) for the duration of trial (6 months) to patients of BPH with LUTS |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
presenting with lower urinary tract symptoms |
|
| ExclusionCriteria |
| Details |
Past history of Prostate surgery, urethral stricture, bladder neck stenosis, vesical calculus, urethral or bladder diverticulum, neurogenic bladder, prostate or bladder cancer |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study improvement in International Prostate symptom score (IPSS) |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of each drug individually |
24 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/07/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare the efficacy of Tamsulosin and Alfuzosin in the treatment of Lower Urinary tract symptoms in a case of Benign Prostate Hypertrophy in a tertiary care centre, all male patients of BPH between the ages of 40 to 80 years are evaluated by taking detailed history, clinical examination, USG KUBP & IPSS scrore. Patients would be randomised into two groups by a computer generated random table. Patients in one group would be given Tab Tamsulosin and other group would be given Tab Alfuzosin. Patients would be reviewed after 06 months and IPSS would be retaken. Pre and post treatment scores would be compared within the group and post treatment groups would be compared between the groups. |