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CTRI Number  CTRI/2025/08/093279 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of Magnitude of Loss of Muscle mass and strength among Adult Patients with long standing liver disease and Its Impact on death rate at 12 months among theses patients at a Tertiary Health Care Centre of North India. 
Scientific Title of Study   Assessment of Magnitude of Sarcopenia among Adult Patients with Liver Cirrhosis and Its Impact on Predicted Twelve-Month Mortality at a Tertiary Health Care Centre of North India 
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 Saurabh Agarwal 
Designation  Professor 
Affiliation  GSVM Medical College  
Address  Room No 24 KPS Institute of Medicine GSVM Medical College Swaroop Nagar Kanpur

Kanpur Nagar
UTTAR PRADESH
208002
India 
Phone  9415039582  
Fax    
Email  dragarwalsaurabh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sharad Kotriwala 
Designation  Junior Resident 
Affiliation  GSVM Medical College 
Address  Room No 24 KPS Institute of Medicine GSVM Medical College Swaroop Nagar Kanpur

Kanpur Nagar
UTTAR PRADESH
208002
India 
Phone  9241780470  
Fax    
Email  kotriwala.sharad@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sharad Kotriwala 
Designation  Junior Resident 
Affiliation  GSVM Medical College 
Address  Room No 24 KPS Institute of Medicine GSVM Medical College Swaroop Nagar Kanpur

Kanpur Nagar
UTTAR PRADESH
208002
India 
Phone  9241780470  
Fax    
Email  kotriwala.sharad@gmail.com  
 
Source of Monetary or Material Support  
GSVM MEDICAL COLLEGE KANPUR Uttar Pradesh India PIN 208002 
 
Primary Sponsor  
Name  GSVM MEDICAL COLLEGE KANPUR 
Address  SWAROOP NAGAR KANPUR Uttar Pradesh India PIN 208002 
Type of Sponsor  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 
SHARAD KOTRIWALA  GSVM Medical College  Room no 24 Department of Medicine
Kanpur Nagar
UTTAR PRADESH 
9241780470

kotriwala.sharad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE GSVM MEDICAL COLLEGE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Age more than or equal to 18 years
Ready to participate in the study as per protocol (Consenting)
Confirmed diagnosis of liver cirrhosis based on
Clinical criteria as Ascites with SAAG ratio equal to or greater than 1.1
presence of esophageal varices
past history of hepatic encephalopathy supported by treatment documents
Biochemical test
Serum Albumin equal to or less than 3.5 mg percent
INR greater than 1.3
Imaging
Nodular liver architecture seen on ultrasound splenomegaly
collateral circulation
portal vein size greater 13 mm
Alcohol abstinence equal to or greater than 3 months
Hemoglobin level equal to or greater than 8 g per dl
Stable subjects with co-morbidities like
diabetes with HbA1c less than 10 percent hypertension with BP less than SBP 140 and DBP less than 90 mm Hg
hypothyroidism or hyperthyroidism with normal thyroid function on appropriate therapy
CKD stage 1& 2
will be eligible for participation. They should be on stable dose for last at least three months.
 
 
ExclusionCriteria 
Details  Acute hepatic decompensation
Jaundice
History of hospitalization in last three months
Malignancy
CKD (stage equal to or greater than 3)
Heart Failure (NYHA III and IV)
COPD GOLD Stage III & IV
Neuromuscular disease (such as myasthenia gravis)
Stroke or other neurologic disorder with residual deficit
Infections like HIV active pulmonary or extrapulmonary TB
Critical illness
Organ transplant or immunosuppression
Pregnancy and lactation
Long-term steroid use (except inhaled or topical)
Bedridden subjects due to their inability in performing the required tests
Subjects having locomotor abnormalities
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Burden of sarcopenia among patients with liver cirrhosis
 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
impact of Sarcopenia among patients with Liver cirrhosis on predicted twelve-month mortality at a tertiary care center of North India
Assessment of quality of life using SARQOL  
Single 
 
Target Sample Size   Total Sample Size="402"
Sample Size from India="402" 
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)   01/09/2025 
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="6"
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  

Cirrhosis is a chronic and irreversible liver disease, characterized by fibrosis and nodular regeneration, which often leads to complications such as ascites, hepatic encephalopathy, and variceal bleeding. In India, the burden of cirrhosis is on the rise, primarily due to hepatitis B and C infections, alcohol misuse, and metabolic-associated steatotic liver disease (MASLD) . These complications significantly reduce survival, with the five-year mortality rate ranging between 20% and 30%. Sarcopenia is defined as a progressive and generalized loss of skeletal muscle mass and strength.  However, awareness regarding sarcopenia remains low among clinicians. In the Indian context, the under diagnosis is further aggravated by limited availability of diagnostic tools such as DEXA scan, Bioelectrical Impedance Analysis (BIA), CT, and MRI . As a result, opportunities for early diagnosis and intervention are often missed, leading to increased morbidity and mortality, prolonged hospitalization, and higher healthcare costs. 

It is estimated that sarcopenia affects 45% to 70% of patients with cirrhosis in the South-East Asian region. In such patients, sarcopenia independently contributes to a two- to three-fold increase in mortality. While it is typically associated with ageing and commonly observed in individuals above 60 years of age, sarcopenia tends to appear much earlier in patients with chronic liver disease (CLD). This early onset is attributed to the catabolic and inflammatory environment caused by hepatic dysfunction, including hyperammonaemia, hormonal imbalances, malnutrition, and physical inactivity. Consequently, there is an increased risk of mortality even at a younger age.

Currently, prognostic models such as the Child-Pugh score are widely used to predict short-term mortality in patients with cirrhosis. However, these models may not adequately reflect the impact of sarcopenia . There is a paucity of Indian data regarding the prevalence of sarcopenia and its prognostic implications in liver cirrhosis. Addressing this gap is crucial, particularly in tertiary care centres where patient load is high.

 
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