Clinical Study For Hospitalized Patients Requiring isocaloric formulafor enteral tube feeding
- Conditions
- Health Condition 1: E631- Imbalance of constituents of foodintake
- Registration Number
- CTRI/2020/09/027831
- Lead Sponsor
- Modi Mundi Pharma Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
1.Ready to Sign informed consent form or informed consent form signed by legally acceptable representatives.
2. Aged 18 years and above.
3. Gender: Male & Female.
4. Hospitalized patients requiring isocaloric formula for enteral feeding.
5. Can tolerate enteral tube feeding.
6. Estimated duration of Hospital stay equal to or greater than 2 days.
1. Receiving tube feeding prior to hospitalization.
2. Patients less than 18 years of age.
3. Patients having allergy to constituents of MaxvidaTM Advance.
4. Any evidence of organ dysfunction or any clinically significant deviation
from the normal, in physical or clinical determinations.
5. History of renal, hepatic, cardiovascular, respiratory, skin, hematological,
endocrine, neurological or gastrointestinal diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study Continuous GI tolerance (Product Compliance): <br/ ><br>a. Diarrhea free day <br/ ><br>b. Stomach irritation <br/ ><br>c. Regurgitation <br/ ><br>d. Abdominal bloating <br/ ><br>e. Vomiting <br/ ><br>f. GRV 500 ml (GRV to be checked at 0730 hrs, 0900 hrs, 1530 hrs, 1700 hrs)Timepoint: Day 1 to Day 5
- Secondary Outcome Measures
Name Time Method 1.To Evaluate Change in BMI during pre and post intervention of the <br/ ><br>study product <br/ ><br>2. To Evaluate Change in serum albumin during pre and post <br/ ><br>intervention of the study product <br/ ><br>3. Adverse event and serious adverse event monitoring based on clinical <br/ ><br>and laboratory AEâ??sTimepoint: Day 1 to Day 5