| CTRI Number |
CTRI/2024/09/073982 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Medical expulsion therapy for lower 1/3 of ureteric stones |
|
Scientific Title of Study
|
A comparative study of Tamsulosin vs. Tamsulosin with Deflazacort in the medical expulsion therapy for lower 1/3 of ureteric stones at TATA MOTORS HOSPITAL, JAMSHEDPUR |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pulakesh kuiti |
| Designation |
DNB Trainee |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of General Surgery Tata Motors Hospital Kharangajhar
Telco colony Jamshedpur Purbi Singhbhum district Jharkhand
Purbi Singhbhum
JHARKHAND
831004
India
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
9074012246 |
| Fax |
|
| Email |
pulakeshkuiti98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kumar |
| Designation |
MS, FRCS, Urosurgeon, Head Medical Services |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of General Surgery Tata Motors Hospital Kharangajhar
Telco colony Jamshedpur Purbi Singhbum Jharkhand
Purbi Singhbhum
JHARKHAND
831004
India
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
7091596028 |
| Fax |
|
| Email |
kumar.sanjay@tatamotors.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Kumar |
| Designation |
MS, FRCS, Urosurgeon, Head Medical Services |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of General Surgery Tata Motors Hospital Kharangajhar
Telco colony Jamshedpur Purbi Singhbum Jharkhand
Purbi Singhbhum
JHARKHAND
831004
India
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
7091596028 |
| Fax |
|
| Email |
kumar.sanjay@tatamotors.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery,
Tata Motors Hospital,
Kharangajhar Telo colony Jamshedpur East Singhbhum Jharkhand 831004 India
|
|
|
Primary Sponsor
|
| Name |
Tata Motors Hospital |
| Address |
Kharangajhar Telo colony Jamshedpur East Singhbhum Jharkhand
831004 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Dr Pulakesh Kuiti |
Tata Motors Hospital |
Department of General Surgery Kharangajhar Telco colony Jamshedpur
Purbi Singhbhum
JHARKHAND |
9074012246
pulakeshkuiti98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,TATA MOTORS HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tamsulosin |
Tamsulosin in the medical expulsion therapy for lower 1/3 of ureteric stones and followed up for 7 days |
| Intervention |
Tamsulosin with Deflazacort |
Tamsulosin with Deflazacort in the medical expulsion therapy for lower 1/3 of ureteric stones and followed up for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ureteric colic
unilateral solitary calculus.
Stone in lower 1/3 ureter demonstrated on a USG KUB/ Plain CT-KUB.
Sizes varying from 5-10 mm were included
|
|
| ExclusionCriteria |
| Details |
Past history of spontaneous stone expulsion within three months, Past history of stone surgery within six months, fever greater than 100F, Gross hydronephrosis, pregnancy, diabetes, renal failure and peptic ulcer, Stones size greater than 10 mm, bilateral stones, impaired kidney functions, urethral stricture, liver disease, patients on beta-blockers, age less than 18 years, patients not willing to receive medical treatment were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of expulsion therapy for lower 1/3 of ureteric stones |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to achieve expulsion therapy for lower 1/3 of ureteric stones |
7 days |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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 4 |
|
Date of First Enrollment (India)
|
21/10/2024 |
| 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 - NO
|
|
Brief Summary
|
In this study, we will compare the effect of Tamsulosin vs. Tamsulosin with Deflazacort in the medical expulsion therapy for lower 1/3 of ureteric stones at TATA MOTORS HOSPITAL, JAMSHEDPUR. I want to perform this study because the result of this study will guide the mode of treatment and evaluate the efficacy of treatment Approval of the institutional ethical committee will be taken before starting the procedure. Written informed consent will be taken prior to the study. Caregivers and patients will be informed about the purpose of the study, and strict confidentiality will be ensured. All the patients fitting into inclusion criteria at IPD/OPD to the Department of General Surgery will be enrolled, and proper history, examination, and relevant investigations will be done. Data collected will be analyzed by preliminary data inspection, content analysis, and interpretation |