| CTRI Number |
CTRI/2019/02/017550 [Registered on: 08/02/2019] Trial Registered Prospectively |
| Last Modified On: |
17/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Use of
Tamsulosin ,Deflazacort and Tadalafil for treatment of patients with lower ureteric calculi.
|
|
Scientific Title of Study
|
A parallel group open labelled randomised controlled
trial to compare the spontaneous passage of lower ureteric calculi 5-10 mm in size, upon usage of Tamsulosin alone as control compared with Tamsulosin and Deflazacort in one arm compared with Tamsulosin, Deflazacort and Tadalafil in the second arm.TAnTALUS
|
| Trial Acronym |
TAnTALUS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jaspreet Singh Sandhu |
| Designation |
Associate Professor |
| Affiliation |
Command Hospital Kolkata |
| Address |
Dept of Surgery
Command Hospital(Eastern Command)
Alipore Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
7607082356 |
| Fax |
|
| Email |
sands46jazz@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Aggarwal |
| Designation |
Assistant professor |
| Affiliation |
Command Hospital Kolkata |
| Address |
Dept of Surgery
Command Hospital(Eastern Command)
Alipore Kolkata
Dept of Surgery
Command Hospital(Eastern Command)
Alipore Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
08800885817 |
| Fax |
|
| Email |
punaggarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abuzar Ahmadi |
| Designation |
Resident |
| Affiliation |
Command Hospital Kolkata |
| Address |
Dept of Surgery
Command Hospital(Eastern Command)
Alipore Kolkata
Dept of Surgery
Command Hospital(Eastern Command)
Alipore Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
09739066828 |
| Fax |
|
| Email |
abuzar.quba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital (Eastern Command ) Kolkata |
|
|
Primary Sponsor
|
| Name |
Dr Jaspreet Singh Sandhu |
| Address |
Dept of Surgery
Command Hospital (Eastern Command) Kolkata 700027 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Abuzar Ahmadi |
Dept Of Surgery Command Hospital (Eastern Command) Kolkata 700027 |
| Dr Puneet Aggarwal |
Dept of Surgery Command Hospital (Eastern Command) Kolkata 700027 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jaspreet Singh Sandhu |
Command Hospital Kolkata |
Dept of Surgery
Command Hospital(Eastern Command)
Alipore Kolkata
Kolkata
WEST BENGAL |
7607082356
sands46jazz@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Command Hospital Kolkata Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N201||Calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control arm |
Tab Tamsulosin 0.4mg orally daily at bedtime for 3 weeks |
| Intervention |
First Arm |
Tab Tamsulosin 0.4mg orally daily at bedtime for 3 weeks,and Tab Deflazacort 30 mg orally daily at bedtime for 3 weeks |
| Intervention |
Second Arm |
Tab Tamsulosin 0.4mg orally daily at bedtime for 3 weeks,and Tab Deflazacort 30 mg orally daily at bedtime for 3 weeks,Tab Tadalafil 10 mg orally daily at bedtime for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1Radiologically proven lower ureteric calculi 5-10mm in size
2Normal Renal function tests
3Those without history of any prior ureteric surgery
|
|
| ExclusionCriteria |
| Details |
1 Infections of the urinary tract(Positive Urine Culture,fever
or leucocytosis
2 Grade 3-4 hydronephrosis
3 Diabetes
4 Peptic ulcer disease,
5 History of hypersensitivity to Tadalafil or Corticosteroids
6 Pregnancy.
7 Systolic blood pressure less than 110 mm Hg during their first visit..
8 History of ureteral surgery
9 Deranged renal function test
10 Patients already on Alfa Blockers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spontaneous Expulsion of the lower third ureteric calculus |
Patients shall be investigated weekly to confirm spontaneous expulsion,for a total of 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total analgesic consumption |
weekly and at 3 weeks |
| Self assesed pain measurement |
Daily and assessed cumulatively at 3 weeks |
| Drug adverse effect of Orthostatic Hypotension |
Earliest appearance and whether causing discontinuation of drug |
| Drug Adverse effect of Headache |
Appearance and whether leading discontinuation of drug |
| Drug adverse effect of Gastritis |
leading to discontinuation of drug or managable with H2 blockers |
| In men,self assessed improvement in (International Index of Erectile Function(IIEF) Scores |
At 03 weeks or whenever discontinuing treatment |
| Failure to continue medical management, and reasons |
Irrespective of time frame |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/02/2019 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A parallel group open labelled randomised controlled trial to compare the spontaneous passage of lower ureteric calculi 5-10 mm in size, upon usage of Tamsulosin 0.4 mg alone as control, compared with Tamsulosin 0.4 mg and Deflazacort 30 mg in one arm and Tamsulosin 0.4 mg , Deflazacort 30mg and Tadalafil 10 mg in the second arm.Patients shall be given the treatment orally, daily for 3 weeks. Patients shall be reviewed weekly, for evidence of passage radiologically. Those unable to pass their calculi spontaneously,shall be treated by ureteroscopy. Adverse events shall also be monitored. |