| CTRI Number |
CTRI/2024/06/068511 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Protein ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How Maxvida High-Protein Formula Affects Adults Needing Tube Feeding with the Same Calories |
|
Scientific Title of Study
|
An Open-label Clinical Study to evaluate the safety and gastrointestinal tolerance (Product Compliance) of Maxvida High Protein in adults requiring isocaloric formula for enteral tube feeding. |
| 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 Pankaj Kumta |
| Designation |
Head of the department and Consultant |
| Affiliation |
KIMS Hospital Enterprises |
| Address |
Department of Critical Care KIMS Hospital Enterprises KONDAPUR
Hyderabad
TELANGANA
500084
India |
| Phone |
9966020073 |
| Fax |
|
| Email |
kumta.pankaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Punit Srivastava |
| Designation |
Chief Scientific Officer |
| Affiliation |
Mediception Science Pvt Ltd. |
| Address |
Unit 711 & 817 Vipul Business Park Sector 48
Gurgaon
HARYANA
122018
India |
| Phone |
8586928449 |
| Fax |
|
| Email |
punit@mediception.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punit Srivastava |
| Designation |
Chief Scientific Officer |
| Affiliation |
Mediception Science Pvt Ltd. |
| Address |
Unit 711 & 817 Vipul Business Park Sector 48
Gurgaon
HARYANA
122018
India |
| Phone |
8586928449 |
| Fax |
|
| Email |
punit@mediception.com |
|
|
Source of Monetary or Material Support
|
| Signtura Health and nutrition |
|
|
Primary Sponsor
|
| Name |
Signtura Health and nutrition |
| Address |
1400 Modi Tower 98 Nehru Place New Delhi 110019 |
| Type of Sponsor |
Other [Nutrition Solutions] |
|
|
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 Pankaj Kumta |
KIMS Hospital |
Department of Critical Care
KIMS Hospital Enterprises
1-112 86 Survey No 5 EE Beside Andhra Bank
Near RTA Office Kondapur Serilingampally Mandal
Hyderabad
TELANGANA |
09966020073
kumta.pankaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS ethics committee of Krishna Institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E898||Other postprocedural endocrine andmetabolic complications and disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Maxvida High protein |
Maxvida high protein is a specially formulated protein powder supplement with high protein high fiber specialized adult nutrition supplement with 33 key nutrients to meet the increased nutritional needs of adults with unintended weight loss for faster recovery.
2 Feeds of 30g in 100ml maxvida high protein will be administered per day. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Ready to Sign informed consent form or informed consent form signed by legally acceptable representatives.
2.Aged more than 18 years
3.Gender: Male & Female.
4.Hospitalized patients requiring isocaloric formula for enteral feeding.
5.Can tolerate enteral tube feeding.
6.Estimated duration of Hospital stays equal to or greater than 2 days.
|
|
| ExclusionCriteria |
| Details |
1.Receiving tube feeding prior to hospitalization.
2.Patients less than 18 years of age.
3.Patients having allergy to constituents of Maxvida High Protein.
4.Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study Continuous GI tolerance (Product Compliance):
a. Diarrhea free day
b. Stomach irritation
c. Regurgitation
d. Abdominal bloating
e. Vomiting
f. GRV less than 500 ml (GRV to be checked at 0730 hours, 0900 hours, 1530 hours, 1700 hours) |
end of hospitalization or 5 days whichever earlier. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To Evaluate Change in weight (kg) during pre and post intervention of the study product
2.To Evaluate Change in serum albumin during pre and post intervention of the study product
3.Adverse event and serious adverse event monitoring based on clinical and laboratory AE’s. |
end of hospitalization or 5 days whichever earlier. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/06/2024 |
| 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="0"
Months="1"
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
|
|
This is an Open-label
Clinical Study to evaluate the safety and gastrointestinal tolerance (Product
Compliance) of Maxvida High Protein in adults requiring isocaloric formula
for enteral tube feeding, Maxvida High Protein is manufactured by Signutra Inc. Primary objectives are
- To study Continuous GI
tolerance (Product Compliance):
- Diarrhea free day
- Stomach irritation
- Regurgitation
- Abdominal bloating
- Vomiting
- GRV less than 500 ml.
Secondary objectives are
- To
Evaluate Change in weight (kg) during pre and post intervention of the
study product
- To Evaluate Change in
serum albumin during pre and post intervention of the study product
- Adverse event and serious adverse event monitoring based on clinical and laboratory AE’s
Total 30 Patients will be enrolled as per inclusion criteria and duration of study will be 30 days.
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