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CTRI Number  CTRI/2023/03/050644 [Registered on: 13/03/2023] Trial Registered Prospectively
Last Modified On: 31/05/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   Effect of Oral nutritional supplement on improving Malnourishment patients in Chronic liver disease (CLD) patients 
Scientific Title of Study   A multi centre, single-arm, prospective interventional study to evaluate the therapeutic effect of oral nutritional supplement on improving malnutrition and sarcopenia in chronic liver disease (CLD) patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Rathod 
Designation  Head - Ideation and Clinical Research 
Affiliation  Dr Reddys Laboratories 
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  04049048400  
Fax  04049048800  
Email  Rahul.Rathod@drreddys.com  
 
Details of Contact Person
Scientific Query
 
Name  Rachana M Bhoite 
Designation  Lead - Nutrition Science & Clinical, Ind, Nutraceutical 
Affiliation  Dr Reddys Laboratories 
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  04049048400  
Fax    
Email  rachanamb@drreddys.com  
 
Details of Contact Person
Public Query
 
Name  Rachana M Bhoite 
Designation  Lead - Nutrition Science & Clinical, Ind, Nutraceutical 
Affiliation  Dr Reddys Laboratories 
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad


TELANGANA
500016
India 
Phone  04049048400  
Fax    
Email  rachanamb@drreddys.com  
 
Source of Monetary or Material Support  
Dr Reddys Laboratories Medical Affairs Department, Dr Reddy Laboratories Ltd, 7-1-27, Ameerpet Road, Ameerpet, Hyderabad Hyderabad TELANGANA 500016 India  
 
Primary Sponsor  
Name  Dr Reddys Laboratories 
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad Hyderabad, TELANGANA 500016 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikileshwar Yandamuri  Aditya Multispecialty Hospitals  3rd Line, Gunturvari Theta, Opp.Road RTC Bus Stand, Kamaraju Scan Centre Road, Guntur, A.P, 522001- India.
Guntur
ANDHRA PRADESH 
0863-2220395

researchaditya26@gmail.com 
Dr Joy Varghese  Gleneagles Global Health City  Gleneagles Global Health City, no: 439, Cheran Nagar, Perumbakka, Chennai - 600100, India
Chennai
TAMIL NADU 
919566062200

joyvargese@gmail.com 
Dr Chandan Kumar  Gleneagles Global Hospitals  5th Floor, Department of Hepatology, 6-1-1070/1 to 4,Lakdikapool ,Hyderabad,500004
Hyderabad
TELANGANA 
04030644444

drchandankn@gmail.com 
Dr Dinesh Jothimani  Rela Hospitals  Dr. Rela Institute & Medical Centre #7, CLC Works Road, Chromepet, Chennai, Tamil Nadu - 600 044, INDIA
Chennai
TAMIL NADU 
9176599555

dinesh.jothimani@relainstitute.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Commitee, Aditya Multispecialty Hospital   Approved 
Institutional Ethics Commitee, Gleneagles Global Hospitals  Approved 
Institutional Ethics Commitee, Gleneagles Global Hospitals, Chennai  Submittted/Under Review 
Institutional Ethics Commitee, Rela Hospitals  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K739||Chronic hepatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Oral Nutritional Supplement (Celevida Liv)  Frequency: 1 to 3 servings per day, prescribed by PI according to the patient protein requirement, based on individual body weight For 3 months. For 1 serve - 30g oral nutritional supplement powder to be mixed with 130 ml of plain water 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age ≥ 18 years to ≤ 65 years’ adults (male or female diagnosed with chronic liver disease) with clinically diagnosed chronic liver disease
2. Malnutrition screening tool i.e., royal free hospital malnutrition tool (See below for details)
3. No gastrointestinal bleeding for at least 4 weeks.
4. No clinical evidence of infection, comorbidities diabetes mellitus.
5. Alcoholic patients who have been abstinent for at least 3 months.
6. No sepsis for less than 4 weeks
7. Hepatocellular carcinoma (HCC) patients can be included.
8. Hepatic Encephalopathy (HE) less than grade three
9. Patients with creatinine less than 1.5mg/dl
10. Patients who are waiting for liver transplant. 
 
ExclusionCriteria 
Details  1. Allergy or contraindications to protein, milk, nuts, or any of the ingredients of the nutritional supplement.
2. All cancers patients except Hepatocellular carcinoma to be excluded.
3. Presence of conditions that would affect normal response to repletion of protein and calories, such as gastrointestinal disorders including inflammatory bowel disease.
4. Patients not able to tolerate the oral nutritional supplements (ONS).
5. Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
ï‚· Change in liver status from baseline, and at the end of treatment, at approximately 3 months as indicated by:
ï‚§ Change in MELD-Na
ï‚§ Change in serum albumin
ï‚§ Change in liver function biomarkers:
a)Gamma glutamyl transpeptidase (GGT),
b)Aspartate transaminase (AST), 
Screening/Basline Day 0(Visit 1),
Telephonic Follow up Week 4 (Visit 2),
Telephonic Follow up Week 8 (Visit 3)
End of study Week 12 (Visit 4) 
 
Secondary Outcome  
Outcome  TimePoints 
ï‚· Changes in body composition particularly in fat and muscle mass and Sarcopenia, as assessed by bioelectrical impedance analysis (BIA) and DEXA Scan from baseline to approximately 3 months.
ï‚· Change in Serum creatinine, international normalized ratio (INR), serum sodium, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides, serum globulin, total bilirubin from baseline to approximately 3 months.
ï‚· Change in plasma glucose and insulin estimated by a combined measure of homeostatic model assessment (HOMA) from baseline to 3 months.
ï‚· Change in quality-of-life indicators as assessed by SF-36, Chronic liver disease questionnaire (CLDQ) and handgrip strength from baseline to approximately 3 months. 
Screening/Basline Day 0(Visit 1),
Telephonic Follow up Week 4 (Visit 2),
Telephonic Follow up Week 8 (Visit 3)
End of study Week 12 (Visit 4) 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/03/2023 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is an single-arm, Multi center, prospective Interventional study to evaluate the effect of oral nutritional supplement on improving malnutrition and sarcopenia  when given one to Three servings per day, prescribed by PI according to the patient protein requirement, based on individual body weight for 3 months in 76 patients (≥ 18 years to ≤65 years) with Chronic Liver disease (CLD) patients that will be conducted in India. The primary endpoint will be to evaluate the impact of oral nutritional supplement on liver and nutritional status from baseline to approximately 3 months in malnourished CLD patients and the secondary endpoint will be to evaluate the impact of oral nutritional supplement, from baseline to approximately 3 months in malnourished CLD patients. 
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