| CTRI Number |
CTRI/2023/09/057471 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
To study the clinical features, causative agent and hematological profile in patients of acute febrile illness with low platelet count ( less than 150k)
|
|
Scientific Title of Study
|
Study of clinical, etiological and hematological profile in patients of acute febrile illness with thrombocytopenia
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveen Kumar |
| Designation |
Junior Resident |
| Affiliation |
Junior Resident |
| Address |
Department of general medicine,
Guru Gobind Singh medical College hospital, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9990778271 |
| Fax |
|
| Email |
naveenrao563@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaminder kaur |
| Designation |
Associate professor |
| Affiliation |
Guru Gobind Singh Medical College hospital faridkot |
| Address |
Department of medicine,Guru Gobind Singh Medical College and hospital, sadique road Punjab India 151203
Faridkot
PUNJAB
151203
India |
| Phone |
8968475537 |
| Fax |
|
| Email |
dr.shaminderkaur1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaminder kaur |
| Designation |
Associate professor |
| Affiliation |
Guru Gobind Singh Medical College hospital faridkot |
| Address |
Department of medicine sadique road Punjab India 151203
Faridkot
PUNJAB
151203
India |
| Phone |
8968475537 |
| Fax |
|
| Email |
dr.shaminderkaur1982@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Gobind Singh Medical College and Hospital Faridkot Punjab India |
|
|
Primary Sponsor
|
| Name |
Dr Naveen Kumar |
| Address |
Department of general medicine, GGSMCH Faridkot sadique road Punjab |
| 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 |
| Dr Naveen Kumar |
Guru Gobind Singh medical College hospital |
Department of general medicine, Guru Gobind Singh medical College hospital Faridkot Punjab
Faridkot
PUNJAB |
9990778271
naveenrao563@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Guru Gobind Singh medical College ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with acute febrile illness with thrombocytopenia
2. Age more than 18 years
|
|
| ExclusionCriteria |
| Details |
1. Known case of platelet function disorder, congenial thrombocytopenia
2. Chronic liver disease
3. Chronic kidney disease
4. Drug, chemotherapy induced thrombocytopenia
5. Known case of hematological malignancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study of clinical hematological and etiological profile in patients of acute febrile illness with thrombocytopenia |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study of clinical etiological & hematological profile in patients with acute febrile illness with thrombocytopenia |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2023 |
| Date of Study Completion (India) |
15/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/07/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Thrombocytopenia is defined as platelet count below 1.50 lakh. Thrombocytopenia commonly associated with acute febrile illness. In our study, we will take 120 patients of acute febrile illness with thrombocytopenia. Clinical, etiological and hematological profile will be studied in these patients. Seasonal variation and severity of bleeding with the platelet count will also be studied. This study will be carried out at Guru Gobind Singh Medical College and Hospital Faridkot. |