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

Phase 3

Completed

Brief Summary: The study is a randomised, placebo controlled, double-blind study to determine the efficacy and safety of Ulinastatin as adjuvant therapy in treatment of Mild or Severe Acute Pancreatitis. Ulinastatin (100000IU)/ Placebo will be given b.d. for 3 days for mild acute pancreatitis and 5 days for severe acute pancreatitis . The primary outcome measure is Number of days for Serum CRP levels to normalize and secondary outcome measures are Mortality, Average length of hospital stay (days) till discharge in survivors and Complications including new onset organ failure. This study will be conducted in twelve centers in India.

Recruitment & Eligibility

Inclusion Criteria

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

Pregnancy or breast-feeding2.
Evidence of chronic pancreatitis on imaging (calcification, ductal irregularity or dilatation)3.
Subjects requiring immediate surgery4.
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.

Primary Outcome Measures

Name	Time	Method
Serum CRP Levels	Day 0,3,5,7,12,22

Secondary Outcome Measures

Name	Time	Method
Mortality	Up to Day 22 or Discharge whichever is earlier
Length Of Hospital Stay (Days)In Survivors.	Up To Day 22 Or Discharge Whichever Is Earlier
Complications, Including New Onset Organ Failure	Up To Day 22 Or Discharge Whichever Is Earlier

Locations (14): Department of Gastrointestinal Surgery,G B Panth Hospital
🇮🇳
Delhi, DELHI, India
B Y L Nair Charitable Hospital and T N Medical College
🇮🇳
Mumbai, MAHARASHTRA, India
Department of Gastroenterology, B J Medical College and Sasoon Hospital
🇮🇳
Pune, MAHARASHTRA, India
Department of Gastroenterology, Seth G.S. Medical College & K.E.M. Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Department of Gastroenterology,Osmania Medical College and General Hospital
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Department of Medicine, B J Medical College and Civil Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Department of Medicine, LTMMC & LTMG Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Department of Medicine, V.S General Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Department of Surgery , Seth G.S. Medical College & K.E.M. Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Department of Surgery, LTMMC & LTMG Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Scroll for more (4 remaining)
Department of Gastrointestinal Surgery,G B Panth Hospital
🇮🇳Delhi, DELHI, India
Dr. Anil Agarwal
Principal investigator
09718599251
aka.gis@gmail.com