A clinical trial to study the effects of Ulinastatin as an adjuvant therapy in treatment of mild or severe acute pancreatitis
Phase 3
Completed
- Conditions
- Health Condition 1: K85- Acute pancreatitisHealth Condition 2: null- Mild or Severe Acute Pancreatitis
- Registration Number
- CTRI/2010/091/001096
- Lead Sponsor
- Bharat Serums and Vaccines Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
I. Age >18years <70years (both inclusive)
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
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 ( ≤ 24 hours)
5. Participation in another investigational study within
30 days before the current study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum CRP LevelsTimepoint: Day 0,3,5,7,12,22
- Secondary Outcome Measures
Name Time Method 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