A clinical trial to study the effects of Ulinastatin as an adjuvant therapy in treatment of mild or severe acute pancreatitis

A prospective, multicentric, double-blind, randomised, phase III clinical study to compare the efficacy and safety of intravenous Ulinastatin versus placebo alongwith standard supportive care in subjects with mild or severe acute pancreatitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001096

Enrollment

150

Registered

2010-08-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K85- Acute pancreatitis Health Condition 2: null- Mild or Severe Acute Pancreatitis

Interventions

Intervention1: Ulinastatin: Mild acute pancreatitis -100000 IU B.D X 3days Severe acute pancreatitis -100000 IU B.D X 5days Control Intervention1: Placebo: Mild Acute Pancreatitis - B.D X 3days Severe

Eligibility

Inclusion criteria

Inclusion criteria: I. Age >18years II. Any two of the following three should be present: 1. Abdominal pain characteristic of acute pancreatitis 2. Serum amylase and/or lipase ≥ 3 times the upper limit of normal 3. Characteristic findings of acute pancreatitis on USG, contrast-enhanced CT or MRI

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breast-feeding 2. Evidence of chronic pancreatitis on imaging (calcification, ductal irregularity or dilatation) 3. Subjects requiring immediate surgery 4. Moribund state in which death was perceived to be imminent ( &#8804; 24 hours) 5. Participation in another investigational study within 30 days before the current study.

Design outcomes

Primary

Measure	Time frame
Serum CRP LevelsTimepoint: Day 0,3,5,7,12,22	—

Secondary

Measure	Time frame
Complications, Including New Onset Organ FailureTimepoint: Up To Day 22 Or Discharge Whichever Is Earlier;Length Of Hospital Stay (Days)In Survivors.Timepoint: Up To Day 22 Or Discharge Whichever Is Earlier;MortalityTimepoint: Up to Day 22 or Discharge whichever is earlier	—

Countries

India

Contacts

Public ContactMrs. Naju Turakhia

dr_pabraham@hindujahospital.com022-24447104

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026