| CTRI Number |
CTRI/2023/09/057395 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
08/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Changes in blood investigation IN DENGUE cases admitted at sir T hospital,gujarat. |
|
Scientific Title of Study
|
HEMATOLOGICAL AND COAGULATION PROFILE IN DENGUE cases admitted at tertiary care center, Bhavnagar. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr kajalben Pravinbhai Prajapati |
| Designation |
1ST YEAR RESIDENT IN PATHOLOGY |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR. |
| Address |
Central hematology laboratory, Sir t hospital campus, jail road, Kalakaua, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9574588108 |
| Fax |
|
| Email |
drkpprajapati@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alpeshpuri Goswami |
| Designation |
ASSOCIATE PROFESSOR IN DEPARTMENT OF PATHOLOGY |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR |
| Address |
Central hematology laboratory, Sir t hospital campus, jail road, Kalakaua, Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9428125028 |
| Fax |
|
| Email |
dralpeshgosai79@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alpeshpuri Goswami |
| Designation |
ASSOCIATE PROFESSOR IN DEPARTMENT OF PATHOLOGY |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR |
| Address |
Central hematology laboratory, Sir t hospital campus, jail road, Kalakaua, Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9428125028 |
| Fax |
|
| Email |
dralpeshgosai79@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| government medical college, Bhavnagar |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR |
| Address |
Bus stand, near state road transport corporation, panwadi, Bhavnagar, gujarat 364001. |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr kajalben Prajapati |
Sir t hospital, Bhavnagar. |
Central hematology laboratory, Sir t hospital campus, jail road, Kalanala, Bhavnagar.
Bhavnagar
GUJARAT |
9574588108
drkpprajapati@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERMENTMEDICALCOLLEGE,BHAVNAGAR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B25-B34||Other viral diseases, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Hospitalised cases of dengue NS1 antigen, Ig M, positive cases
|
|
| ExclusionCriteria |
| Details |
Other conditions associated with dengue which include similar hematological changes like ITP, Aplastic anemia, infections leading to thrombocytopenia, bone marrow failure, cancer, exposure to radiotherapy etc.
Drugs affecting the hematological profile and coagulation profile like warfarin, heparin, antiplatelate drugs ,anticancer drug etc..
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| to assess the hematological dynamics of patients with dengue fever in order to increase the sensitivity of the screening by healthcare professionals in the most serious cases. |
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to identify laboratory markers that may indicate the severity and outcome of disease. |
15 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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After approval from the scientific review committee and ethics committee, study will be carried out in hematology central laboratory, Sir T hospital, Bhavnagar. After taking permission from medicine department & peadiatric department, patient’s blood sample will be selected on basis of inclusion and exclusion criteria. Patient’s blood sample will be given a unique id no and patient’s identity will not be disclosed. Data taken from patient’s blood sample sent for routine investion at central laboratory,sir t hospital, Bhavnagar. Reading of hematological parameter and coagulation profile will be noted. Data will be analysed and compile in master chart. After tabulation of data, statistical analysis will be done.
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