An interventional trial to assess the efficacy of ulinastatin to reduce the number of days stayed in Intensive Care Unit and in the hospital for patients diagnosed with acute severe to moderately severe pancreatitis.

Effect Of Ulinastatin As An Auxillary Drug In Reducing Mortality And Morbidity In Severe Acute Pancreatitis – A Randomised Control Open Labelled Study. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070450

Enrollment

Registered

2024-07-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Interventions

Intervention1: Inj Ulinastatin 200000 IU in 100ml ND/D5 IV BD for 5 days: Inj Ulinastatin 200000 IU in 100ml ND/D5 IV BD for 5 days is given in addition to standard treatment as per IAP protocol Contr

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinical Presentation: Presence of any two of the following three criteria: A.Upper abdominal pain characteristic of acute pancreatitis (acute onset of persistent, severe, epigastric pain often radiating to the back). B.Serum amylase and/or lipase levels three times the upper limit of normal (amylase: 40-140 units/litre, lipase: 0-160 units/litre). C.Characteristic findings of acute pancreatitis on CT or ultrasonography. 2. Diagnosis of moderately severe or severe acute pancreatitis, based on the revised Atlanta classification for acute pancreatitis. 3. Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) pancreatitis. 4. Pancreatitis with multiorgan dysfunction.

Exclusion criteria

Exclusion criteria: 1.Exclusion of cases with mild pancreatitis, defined by the absence of organ failure, local, or systemic complications. 2.Pregnancy or Nursing. 3.Recent Participation in Clinical Studies. 4.Pancreatic Cancer. 5.Non-Participation Willingness.

Design outcomes

Primary

Measure	Time frame
Reduce the morbidity rate in form of abdominal pain and number of days stayed in hospitalTimepoint: Assessed on day 0, day 3, day 28 or at discharge	—

Secondary

Measure	Time frame
Reduce the case fatality rateTimepoint: Assessed from day 0 to day 28 or discharge & once at day 90	—

Countries

India

Contacts

Public ContactAbishek Prasenaa A

SRMMCH and RC Kattankulathur campus

hod.gensur.ktr@srmist.edu.in9441074743

Outcome results

None listed

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