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CTRI Number  CTRI/2024/04/066306 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 20/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   understanding how blood tests and a scoring system called MELD relate in people with Alcoholic liver disease helps doctors to make decisions about patient care and to anticipate future outcomes. 
Scientific Title of Study   Correlation of Hematological Parameters and MELD score in patients with Alcoholic Liver Disease : Observational study.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dudhat Kinjal  
Designation  R1,Department of Pathology, GMC Bhavnagar 
Affiliation  Govt. Medical College, Bhavnagar 
Address  Department of Pathology 3rd floor, Sir T Hospital & Govt. Medical college, Bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9327488712  
Fax    
Email  kinjidudhat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alpeshpuri Goswami 
Designation  Associate Professor 
Affiliation  Govt. Medical College, Bhavnagar 
Address  Department of Pathology, Gov. Medical College, Bhavnagar, Gujarat 364001

Bhavnagar
GUJARAT
364001
India 
Phone  09428125028  
Fax    
Email  dralpeshgosai79@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Alpeshpuri Goswami 
Designation  Associate Professor 
Affiliation  Govt. Medical College, Bhavnagar 
Address  Department of Pathology, Gov. Medical College, Bhavnagar, Gujarat 364001

Bhavnagar
GUJARAT
364001
India 
Phone  09428125028  
Fax    
Email  dralpeshgosai79@yahoo.co.in  
 
Source of Monetary or Material Support  
Sir Takhtsinhji Hospital and Gov Medical College, Bhavnagar 
 
Primary Sponsor  
Name  Dr Kinjal Dudhat 
Address  Sir Takhtsinhji Hospital and Gov Medical College, Bhavnagar 364001,Gujarat, India 
Type of Sponsor  Other [Government Medical College] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kinjal Dudhat  Room no 41,Central laboratory, Department of pathology   Sir Takhtsinhji Hospital and Gov Medical College, Bhavnagar
Bhavnagar
GUJARAT 		 9327488712

kinjidudhat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Government Medical College,Bhavnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R198||Other specified symptoms and signsinvolving the digestive system and abdomen,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All sample received from OPD and IPD belonging of age more than equal to 18 years and both gender diagnosed with Alcoholic Liver Disease. 
 
ExclusionCriteria 
Details  Patients with a known case of primary coagulation disorders, Renal disease, Non Alcoholic Liver Disease, severe Infections and immunocompromised patients. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Assess MELD score and MELD group in patients with Alcoholic liver disease
To Assess Biochemistry parameters in patients with Alcoholic liver disease
To Assess the proportion of Anemia in both gender of patients with Alcoholic Liver Disease
To Assess the proportion of Normal Platelet count, thrombocytosis and thrombocytopenia in patients with Alcoholic Liver Disease
To Assess the proportion of leukocytosis, leukopenia and normal leukocyte count in patients with Alcoholic liver disease
To determine association between hematological parameters and MELD score.

 		 15 Months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   01/05/2024 
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="3"
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   Alcoholic liver disease (ALD) is a spectrum of liver disorders caused by excessive and prolonged alcohol consumption. It encompasses a range of conditions, including fatty liver, alcoholic hepatitis, cirrhosis and hepatocellular carcinoma. ALD is one of the leading causes of liver related morbidity and mortality worldwide. Abnormalities in hematological parameters and MELD score are associated with increased risk of complications, including bleeding and infection. All these parameters determine a greater extend of mortality and morbidity in these patients. The principle goal is to establish a single score resulting from the sum of subset of individual variables, each being supposed to weigh on the disease progression.
The model for End-Stage liver disease score is a numerical scale developed to assess the severity of liver disease. MELD score incorporates three laboratory values : serum bilirubin, serum creatinine, and international normalized ratio(INR)
MELD Score (Model for End stage Liver Disease Score): 
9.6 loge(creatinine mg/dl ) + 3.8 loge(Bilirubin mg/dl) + 11.2 loge (INR) +6.4
By assessing hematological parameters and calculating the MELD score, severity of Alcoholic liver disease can be assessed so, the clinician can make decisions regarding the managment and prognosis of patients with Alcoholic Liver Disease.
 
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