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CTRI Number  CTRI/2024/06/068302 [Registered on: 04/06/2024] Trial Registered Prospectively
Last Modified On: 31/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A study on treatment outcome and electrolyte disturbance in chronic liver disease  
Scientific Title of Study   A study On Treatment Outcome And Electrolyte Disturbance In Chronic Liver Disease With Hepatic Encephalopathy And Non-Hepatic Encephalopathy In Tertiary Care Hospital 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thaiba jabeen G 
Designation  student 
Affiliation  karavali college of Pharmacy, Mangalore 
Address  Department of Pharmacy Practice, Karavali college of pharmacy, Vamanjoor, Mangalore, Karnataka-575028 Dakshina Kannada KARNATAKA 575028 India

Dakshina Kannada
KARNATAKA
575028
India 
Phone  9686476122  
Fax    
Email  thaibajabeen@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Adarsh V V 
Designation  Assistant professor 
Affiliation  karavali college of Pharmacy, Mangalore 
Address  Department of Pharmacy Practice, Karavali college of pharmacy, Vamanjoor, Mangalore, Karnataka-575028 Dakshina Kannada KARNATAKA 575028 India

Dakshina Kannada
KARNATAKA
575028
India 
Phone  7907913261  
Fax    
Email  dradarshvv@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Adarsh V V 
Designation  Assistant professor 
Affiliation  karavali college of Pharmacy, Mangalore 
Address  Department of Pharmacy Practice, Karavali college of pharmacy, Vamanjoor, Mangalore, Karnataka-575028 Dakshina Kannada KARNATAKA 575028 India

Dakshina Kannada
KARNATAKA
575028
India 
Phone  7907913261  
Fax    
Email  dradarshvv@gmail.com  
 
Source of Monetary or Material Support  
Father Muller Medical College Hospital, Mangalore, Karnataka-575028 Dakshina kannada karnataka 575028 India 
 
Primary Sponsor  
Name  Thaiba jabeen G 
Address  Department of Pharmacy Practice, Karavali college of Pharmacy, Vamanjoor, Mangalore, Karnataka-575028 
Type of Sponsor  Other [Self] 
 
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 
Thaiba jabeen G  Father Muller Medical College Hospital  Father Muller Medical college hospital, Department of General medicine, 1st floor, Kankanady, Mangalore-575002 Dakshina Kannada, KARNATAKA
Dakshina Kannada
KARNATAKA 		 9686476122

thaibajabeen@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K769||Liver disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Both male and female patients above 18 years of age
Both patients with chronic liver disease with hepatic encephalopathy and non hepatic encephalopathy will be included
Diagnosed hepatic encephalopathy within the past 6 months 
 
ExclusionCriteria 
Details  Pregnant and lactating women
Previous liver transplantation
Lack of biochemical and imageology examination
Co-infection with HCV, HAV, HEV, HIV and chronic kidney failure and heart failure patients
Patients with hepatocellular carcinoma 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study results will give an overview of the treatment outcomes in the chronic liver disease and also, how will electrolyte disturbance occurs in chronic liver disease with hepatic encephalopathy and non hepatic encephalopathy.   0 15 30days  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="141"
Sample Size from India="141" 
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)   15/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/06/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Hepatic encephalopathy is a broad term that refer to a variety of brief and reversible neurological and mental symptoms that are frequently observed in people with chronic liver disease and portal hypertension , but can also occur in people with abrupt liver failure. A estimated one- and three-year survival rate without liver transplantation of 42% and 23%, respectively, is predicted when hepatic encephalopathy develops in 50% to 70% of patients with cirrhosis. In this study main objective is to study the correlation between electrolyte disturbance and hepatic encephalopathy in chronic liver disease. To compare treatment outcome and effects of electrolyte disturbance in chronic liver disease patients with hepatic encephalopathy and non hepatic encephalopathy. and also evaluate the relationship between hypomagnesaemia and hepatic encephalopathy and compare the effectiveness of combination of both lactulose and rifaximin or lactulose alone in hepatic encephalopathy patients. Need of the study is to monitor and compare treatment outcome an effect of electrolyte disturbance in chronic liver disease patients with hepatic encephalopathy and non hepatic encephalopathy. Then, lactulose is commonly used in the treatment of hepatic encephalopathy, however there are increasing evidence of add-on therapy with rifaximin. There are less study conducted using lactulose-rifaximin and lactulose alone. We aimed to study the effectiveness and outcome of lactulose-rifaximin combination with lactulose alone and also the effect of electrolyte disturbance in chronic liver disease with hepatic encephalopathy and non hepatic encephalopathy patients.  
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