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Clinical Trials/CTRI/2023/08/056773
CTRI/2023/08/056773Not yet recruitingUnknown

A Multi-center, Open Label, Single Arm, Prospective, Observational Study to Evaluate the Effectiveness and Safety of Whey Protein Isolate (WPI) Based Nutritional Supplement in Coronary Artery Bypass Surgery (CABG) Patients - NI

Otsuka Pharmaceutical India Pvt Ltd0 sites0 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
Unknown
Status
Not yet recruiting
Sponsor

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Inclusion Criteria

  • 1. Patients with age of = 18 to 70 years and with the clinical diagnosis of CAD (coronary artery disease) undergoing CABG surgery.
  • 2. Patients/LAR who are willing to provide voluntary written informed consent to participate in the study.
  • 3. Patients receiving nutrition as per standard care.
  • 4. Expected length of ICU/hospital stay is minimum 5 days.
  • 5. Patients who in the opinion of physician are suitable to receive oral WPI based nutritional supplement.
  • 6. Patients who will be able to adhere to study visit schedule and other protocol requirements.
  • After the screening and confirmation, the patient will receive Whey Protein Isolate based nutritional supplement 24-48 hrs. after the CABG surgery based on discretion of physician/dietician for 30 days

Exclusion Criteria

  • 1. Patients taking enteral (tube feeding) or parenteral nutritional supplements or any other form of protein supplement.
  • 2. Patients having known allergy or contraindication for use of WPI based nutritional supplements.
  • 3. Pregnant or breastfeeding women.
  • 4.Patients with BMI >30 kg/m2.
  • 5. Patient with severe and life-threatening complication(s) or patients who are unlikely to survive the next 48-72 hrs. at the time of enrollment (as per physician’s discretion).
  • 6. Patients using other experimental drugs or participating in other clinical trial in the prior one month.
  • 7. Any clinical condition that would preclude participation in the study as per investigator’s opinion.

Investigators

Sponsor
Otsuka Pharmaceutical India Pvt Ltd

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