| CTRI Number |
CTRI/2023/12/060881 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutrition Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improvement in Muscle Mass with Nutrition in Patients with Liver Cirrhosis |
|
Scientific Title of Study
|
Change in Muscle Mass with Nutritional Therapy in Cirrhotic Patients - A Randomized Controlled 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 |
Sudhir Maharshi |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Gastroenterology, Sawai Man Singh Medical college, Jaipur, India
Jaipur
RAJASTHAN
302004
India |
| Phone |
8130369247 |
| Fax |
|
| Email |
sudhir.maharshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandeep Njhawan |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Gastroenterology, Sawai Man Singh Medical College, Jaipur, India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829272233 |
| Fax |
|
| Email |
sandeepnijhawan16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAKSHAM SETH |
| Designation |
Senior Resident |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Gastroenterology, Sawai Man Singh Medical College Jaipur, India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9916475671 |
| Fax |
|
| Email |
seth_saksham@yahoo.in |
|
|
Source of Monetary or Material Support
|
| S.M.S Medical College,Jaipur Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College |
| Address |
S.M.S Medical College, Rajasthan , India |
| 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 |
| DR SUDHIR MAHARSHI |
Sawai Man Singh Medical College |
Dept of Gastroenterology
Jaipur
RAJASTHAN |
8130369247
sudhir.maharshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of The Ethics Committee, S.M.S Medical College and Attached Hospital Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K703||Alcoholic cirrhosis of liver, (2) ICD-10 Condition: K74||Fibrosis and cirrhosis of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No nutritional therapy |
Patients continuing there normal diet |
| Intervention |
Nutrition Therapy |
Calorie - 30-35 kcal/kg/day
Protein - 1.2 - 1.5 gm/kg/day
Duration - 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All patients with Liver Cirrhosis
Sarcopenia |
|
| ExclusionCriteria |
| Details |
Patients with hepatic encephalopathy (grade≥ II according to the WestHaven Grading System).
Uncontrolled esophageal varices bleeding.
Refractory ascites.
Malignancy.
Patients with HPS or Portopulmonary Syndrome
Severe renal dysfunction (estimated glomerular filtration rate< 30 ml/min/1.73 m2).
Severe cardiac disease, history of gastrectomy.
Patients with Neurological Disorders
Previous poor compliance with pharmacologic treatment or nutritional counseling before initiating the trial supplement.
Patients with a history of hepatocellular carcinoma.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the Change in Muscle Mass |
0,1,3 & 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in albumin level, anthropometry parameters (mid arm circumference, triceps skin fold thickness, hand grip)
Improvement in CTP & MELD score.
Hospital admission
Mortality |
0,1,3 & 6 months |
|
|
Target Sample Size
|
Total Sample Size="194"
Sample Size from India="194"
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)
|
25/01/2024 |
| 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 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
|
Sarcopenia is defined
as muscle wasting (progressive and generalized loss of muscle mass) together
with a decline of muscle function (loss of strength or physical performance).Sarcopenia has been associated with poorer survival in patients with cirrhosis. Nutrition may very well have direct influence on sarcopenia and functional status.There is no study on nutritional management of patients with sarcopenia. We will perform a randomized controlled study to assess the effects of nutritional therapy on sarcopenia in patients of cirrhosis. |