| CTRI Number |
CTRI/2024/05/067728 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Laboratory tests for identification of liver disease patients. |
|
Scientific Title of Study
|
Evaluation of Hematological and Biochemical Parameters for Early Diagnosis of Chronic Liver Disease Patients and Normal Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarti Tuljagir Giri |
| Designation |
Post Graduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Central Clinical Laboratory, Ground Floor, AVBRH, Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9370891687 |
| Fax |
|
| Email |
aarticutiepie4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kaustubh Kharche |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Central Clinical Laboratory, Ground Floor, AVBRH,Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8793773277 |
| Fax |
|
| Email |
kkaustubh9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaustubh Kharche |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Central Clinical Laboratory, Ground Floor,AVBRH,Sawangi Wardha
MAHARASHTRA
442001
India |
| Phone |
8793773277 |
| Fax |
|
| Email |
kkaustubh9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Sawangi Meghe, Wardha-442001 India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha-442001, India. |
| Type of Sponsor |
Private 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 |
| Aarti Tuljagir giri |
Acharya Vinoba Bhave Rural Hospital |
Central Clinical Laboratory, Ground Floor, Sawangi Meghe Wardha-442001
Wardha
MAHARASHTRA |
9370891687
aarticutie4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K768||Other specified diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic liver disease patients in decompensation, whose signs and symptoms
2. There are both genders present.
3. Age group continuing for more than six months is 20–60 years old. |
|
| ExclusionCriteria |
| Details |
1.Sudden collapse of liver cells
2. Patients with endotoxemia or septicemia from sources other than main liver causes, as well as liver cell failure following an infectious aetiology. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Factors associated with and haematological Parameters for Early Dignosis of Chronic Liver Disease Patients |
Assessment will be done at the end of 18 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
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)
|
22/07/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The final stages of chronic liver disease (CLD) are fibrosis and cirrhosis, which are caused by a gradual deterioration of the liver echotexture. Increased rates of morbidity and mortality can result from coexisting problems including bleeding and infections. There are occasions when it is linked to abnormalities in the blood. Numerous underlying factors can contribute to CLD, such as nutritional inadequacies, bleeding, excessive alcohol use, and anomalies in the hepatic protein manufacturing process or in the production of proteins involved in blood formation or coagulation. All things considered, a wide range of distinct haematological illnesses are associated with CLD. This study aims to evaluate the hematological and biochemical parameters for early diagnosis of Chronic Liver Disease Patients and Normal Patients.
|