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
|
|
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
|
|
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. |