| CTRI Number |
CTRI/2022/07/044506 [Registered on: 29/07/2022] Trial Registered Prospectively |
| Last Modified On: |
29/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prospective Study to Analyze the Profile of Urinary Tract Infections in Diabetes Mellitus Patients presenting at Tertiary Care Centre in Navi Mumbai |
|
Scientific Title of Study
|
Prospective Study to Analyze the Profile of Urinary Tract Infections in Diabetes Mellitus Patients presenting at Tertiary Care Centre in Navi Mumbai:Clinical and Microbiological Profile |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijayalaxmi Pujari |
| Designation |
PG Scholar |
| Affiliation |
Dr D.Y.Patil deemed to be university Nerul Navi Mumbai |
| Address |
Department of Medicine ,School Of Medicine,Dr D.Y.Patil Hospital and deemed to be University ,Sector-5 Nerul ,Navi Mumbai .
Thane
MAHARASHTRA
400706
India |
| Phone |
9890004225 |
| Fax |
|
| Email |
vijayalaxmi.pujari13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalaxmi Pujari |
| Designation |
PG Scholar |
| Affiliation |
Dr D.Y.Patil deemed to be university Nerul Navi Mumbai |
| Address |
Department of Medicine ,School Of Medicine,Dr D.Y.Patil Hospital and deemed to be University ,Sector-5 Nerul ,Navi Mumbai .
Thane
MAHARASHTRA
400706
India |
| Phone |
9890004225 |
| Fax |
|
| Email |
vijayalaxmi.pujari13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santwana Chandarkar |
| Designation |
Professor |
| Affiliation |
Dr D.Y.Patil deemed to be university Nerul Navi Mumbai |
| Address |
Department of Medicine ,School Of Medicine,Dr D.Y.Patil Hospital and deemed to be University ,Sector-5 Nerul ,Navi Mumbai .
Thane
MAHARASHTRA
400706
India |
| Phone |
09820505489 |
| Fax |
|
| Email |
Santwana.chandrakar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| School Of Medicine,Dr D.Y.Patil Hospital and deemed to be University |
|
|
Primary Sponsor
|
| Name |
Dr Vijayalaxmi Pujari |
| Address |
Department of Medicine ,School Of Medicine,Dr D.Y.Patil Hospital and deemed to be University ,Sector-5 Nerul ,Navi Mumbai . |
| Type of Sponsor |
Other [Self ] |
|
|
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 Vijayalaxmi Pujari |
Dr D.Y.Patil Hospital and deemed to be University |
Department of Medicine
Dr D.Y.Patil Hospital and deemed to be University ,Sector-5 Nerul ,Navi Mumbai .
Thane
MAHARASHTRA |
9890004225
vijayalaxmi.pujari13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
All patients with Type 1 or Type 2 Diabetes Mellitus
All patients presenting with UTI or detected as UTI |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study urinary tract infections in Diabetes Mellitus depending upon the part of urinary tract involved |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study clinical and microbiological profile of urinary tract infections in Diabetes Mellitus |
1 year |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2022 |
| 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 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)?
Response - NO
|
|
Brief Summary
|
The present study is the clinical observational study for completion under Dr D.Y.PATIL deemed to be University Total duration of trial is 1 year
TITLE:PROSPECTIVE STUDY TO ANALYZE THE PROFILE OF URINARY TRACT INFECTIONS IN DIABETES MELLITUS PATIENTS PRESENTING AT TERTIARY CARE CENTRE IN NAVI MUMBAI :CLINICAL AND MICROBIOLOGICAL PROFILE
STUDY GROUP:Sample size 100
STUDY CENTRE :School of Medicine Dr D.Y.PATIL deemed to be university and hospital ,nerul,navi mumbai
PG SCHOLAR:Dr Vijayalaxmi Pujari
GUIDE:Dr Santwana Chandarkar |