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A study comparing Pancreatic enzymes versus similar looking placebo tablets to improve outcomes in acute pancreatitis

Effect of Pancreatic Enzyme Supplementation on 90-days hospital free alive days in patients with Acute Necrotizing Pancreatitis (ANP): A multicenter double blinded placebo-controlled randomizedTrial - PEAP trial

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085484
Enrollment
248
Registered
2025-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K859- Acute pancreatitis, unspecified

Interventions

Intervention1: Oral pancreatic enzyme supplementation: pancreatic enzyme supplementation - 2 Tablets/ meal, each containing: Equivalent to Lipase 25000 USP units, Amylase 74700 USP units, Protease 625

Sponsors

The Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Acute pancreatitis with pancreatic necrosis within 28 days of pain, Able to take oral or enteral feed, pancreatic necrosis more than 30 percentage

Exclusion criteria

Exclusion criteria: Patients with Chronic Pancreatitis, Patients with more multi-organ failure at time of screening, Patient on ventilatory support, Pregnancy, Contraindication to enteral feeding or not tolerating enteral feed, Age lesser than 18 years or more than 75 years, Major comorbidity such as decompensated cirrhosis heart failure significant lung parenchymal or airway disease advanced chronic kidney disease, Previous pancreatic surgery, Known allergy to pancreatic enzyme supplementation components

Design outcomes

Primary

MeasureTime frame
Days alive and out of hospital at 90 days. It will be counted as number of days the patient is not in hospital and alive. This parameter will take into account total duration of readmissions and mortality. DAOH90= Number of days alive (within 90 days of follow up) (Total hospitalization days at readmission).Timepoint: 90 days

Secondary

MeasureTime frame
a. All cause mortality b. Mean change in body weight from baseline in both groups c. Mean change in mid upper arm circumference at from baseline in both groups Timepoint: day 30, day 60 & day 90;Mean change in PAN PROMISE score as a measure of health related quality of life Timepoint: day 90

Countries

India

Contacts

Public ContactSudipta Dhar Chowdhury

Christian Medical College, Vellore

sudipta@cmcvellore.ac.in04172224870

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026