| 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
|
|
|
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
|
|
|
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. |