Health Condition 1: E631- Imbalance of constituents of foodintake
Conditions
Interventions
Intervention1: MaxvidaTM HPHF: � 2 Feeds to be administered per day at 0800 Hrs and 1600 Hrs
o 45 g of MaxvidaTM HPHF will be diluted in water as per investigator�s discretion to prepare
Sponsors
Modi Mundi Pharma Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 enteral feeding. 5 Can tolerate enteral tube feeding. 6 Estimated duration of Hospital stay equal to or greater than 2 days.
Exclusion criteria
Exclusion criteria: 1. Receiving tube feeding prior to hospitalization. 2. Patients less than 18 years of age. 3. Patients having allergy to constituents of MaxvidaTM HPHF. 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. To Evaluate Change in BMI 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 AEââ?¬â?¢s Timepoint: Day 1 to Day 5 | — |
Primary
| Measure | Time frame |
|---|---|
| 1. To study Continuous GI tolerance (Product Compliance): a. Diarrhea free day b. Stomach irritation c. Regurgitation d. Abdominal bloating e. Vomiting f. GRV 500 ml (GRV to be checked at 0730 hrs, 0900 hrs, 1530 hrs, 1700 hrs) Timepoint: Day 1 to Day 5 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
Cliniexperts
Outcome results
None listed