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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 ( &#8804; 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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