| CTRI Number |
CTRI/2020/04/024503 [Registered on: 07/04/2020] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Nutraceutical
Other (Specify) [Nutrition intervention] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study the effect of Early Nutrition support on recovery of patients with Pancreatitis |
|
Scientific Title of Study
|
Impact of Early Nutrition Support on Clinical and Metabolic outcomes in Subjects with Pancreatitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AKSHATHA N |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
UNIVERSITY OF MYSORE |
| Address |
Department of Studies in Food Science and Nutrition
Manasagangothri , university of Mysore
Mysore
Mysore
KARNATAKA
570006
India |
| Phone |
9481833466 |
| Fax |
|
| Email |
akshatha.nash4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ASNA UROOJ |
| Designation |
Chairperson |
| Affiliation |
UNIVERSITY OF MYSORE |
| Address |
Department of Studies in Food Science and Nutrition
Manasagangothri , university of Mysore
Mysore
Mysore
KARNATAKA
570006
India |
| Phone |
9448489334 |
| Fax |
|
| Email |
asnau321@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AKSHATHA N |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
UNIVERSITY OF MYSORE |
| Address |
Department of Studies in Food Science and Nutrition
Manasagangothri , university of Mysore
Mysore
Mysore
KARNATAKA
570006
India |
| Phone |
9481833466 |
| Fax |
|
| Email |
akshatha.nash4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Food science and nutrition, University of Mysore |
|
|
Primary Sponsor
|
| Name |
DrAsna Urooj |
| Address |
Professor
Department of Food Science and nutrition Manasagangothri Mysore |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| AKSHATHA N |
APOLLO BGS HOSPITALS |
ADICHUNCHANGIRI ROAD, kUVEMPUNAGAR,MYSURU-570023
Mysore
KARNATAKA |
9481833466
akshatha.nash4@gmail.com |
| AKSHATHA N |
COLUMBIA ASIA HOSPITAL |
NO 85-86, BANGALORE MYSORE RING ROAD JUNCTION BANNIMANTAPA A LAYOUT, SIDDIQUE NAGAR MANDI MOHALLA MYSURU 570015
Mysore
KARNATAKA |
9481833466
akshatha.nash4@gmail.com |
| AKSHATHA N |
JSS HOSPITAL |
JSS HOSPITAL ROAD, RAMACHANDRA AGRAHARA, MYSURU 570004
Mysore
KARNATAKA |
9481833466
akshatha.nash4@gmail.com |
| AKSHATHA N |
K R HOSPITAL |
IRWIN ROAD MYSURU 570001
Mysore
KARNATAKA |
9481833466
akshatha.nash4@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee Columbia Asia Hospital |
Approved |
| Instituitional Ethics Committee KR Hospital |
Approved |
| instituitional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E168||Other specified disorders of pancreatic internal secretion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Disease specific Nutrition Formulation with immuno nutrition agents in safe limit |
Patients will be administered with prepared formulation orally or enterally within 48 hrs of admission until discharge. |
| Comparator Agent |
patients on regular hospital kitchen feeds or commercial feeds as per hospital protocol |
These patients are fed with regular feeds with no immune nutrition added and are observed until discharged.patients are not necessarily started feeds within 48 hrs of admission |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
subjects diagnosed with Pancreatitis and who have accessable Gastrointestinal tract for feeding either rally or enterally.
both acute and chronic subects will be included. |
|
| ExclusionCriteria |
| Details |
Subjects who are haemodynamically unstable and whose gastrointestinal tract cannot be accessed for oral or enteral feeds.
Pregnant females with pancreatitis and patients with renal and or cardiac complications are excluded. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in Antioxidant levels of patients in case group, improvement in clinical and metabolic outcomes evidenced by biochemical parameters |
day 1,3,7 and during time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in length of hospital stay as compared to control group |
time of discharge |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/01/2021 |
| Date of Study Completion (India) |
30/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized , case control study where a disease specific formulation with immuno nutrition will be given orally or enterally to patients with Pancreatitis who are admitted to hospital. Clinical and Metabolic outcomes of patients will be analysed for improvement and decreased length of hospital stay. The formula will be fortified with micronutrients and immuno nutrients in the safe limit. Intervention will be started within the 48 hours after admission and will be continued until discharge. Recruitment of subjects will be conducted in various hospitals in Mysore district. The primary outcome and secondary outcome will be measured using biochemical parameters and and clinical signs and symptoms. |