| CTRI Number |
CTRI/2019/02/017544 [Registered on: 07/02/2019] Trial Registered Retrospectively |
| Last Modified On: |
06/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Determining laboratory reference ranges |
|
Scientific Title of Study
|
Determination of laboratory reference intervals in healthy Indian adults at a tertiary referral centre |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/OA-95/2015 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNithya Gogtay |
| Designation |
ProfessorAdditional |
| Affiliation |
SethGSMedicalcollegeandKEMHospital |
| Address |
Department of Clinical Pharmacoloy, First Floor New multistorey building Seth GS Medical College and KEM Hospital Acharya Donde Marg Parel
FirstFloorNewmultistorey buildingSethGSmedicalcollege andKEM HospitalAcharyaDonde MargParel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24133767 |
| Fax |
2224112871 |
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNithya Gogtay |
| Designation |
ProfessorAdditional |
| Affiliation |
SethGSMedicalcollegeandKEMHospital |
| Address |
Seth GS Medical College and KEM Hospital, First Floor New multistorey building Acharya Donde Marg, Parel
FirstFloorNewmultistorey buildingSethGSmedicalcollege andKEM HospitalAcharyaDonde MargParel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24133767 |
| Fax |
2224112871 |
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MsBrinalFiger |
| Designation |
PhD Student |
| Affiliation |
SethGSMedicalcollegeandKEMHospital |
| Address |
FirstFloorNewmultistorey buildingSethGS medicalcollege andKEMHospitalAcharyaDonde MargParel
FirstFloorNewmultistorey buildingSethGSmedicalcollege andKEM HospitalAcharyaDonde MargParel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24133767 |
| Fax |
2224112871 |
| Email |
brinz19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research Society,seth GSMC and KEMH,Parel,Mumbai |
|
|
Primary Sponsor
|
| Name |
Research Society Seth GSMC and KEM Hospital |
| Address |
Seth GS Medical College and KEM Hospital,Acharya Donde Marg,Parel, Mumbai |
| 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 |
| MsBrinalFiger |
Seth GS Medical College and KEM Hospital |
First floor, new MS building Acharya Donde Marg Parel, Mumbai
Mumbai
MAHARASHTRA |
02224133767
24112871
brinz19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutionalethicscomitte1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
noabnormality |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Adults above 18 years of age |
|
| ExclusionCriteria |
| Details |
presenceofhealthabnormalities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establishlaboratoryreferencerangesforhealthyindianadults |
After processing the samples. Reference values obtained after analysis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessimpactofvariableslikesocioeconomicstratagenderageanddiet |
There are no time points in specific. The impact of variables will be assessed during analysis of the data using logistic regression. |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/04/2016 |
| Date of Study Completion (India) |
30/09/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study is being conducted to determine laboratory reference ranges in healthy indian adults. In this study we will determine laboratory reference ranges as per CLSI guidelines. The eligibility criteria as specified by the CLSI guidelines will be applied. only one visit is planned for each participant and 5ml blood will be withdrawn. All hematology and biochemistry laboratory parameters will be determined for the participants. |