A CLINICAL TRIAL TO ANALYZE THE EFFECT OF RECTAL INDOMETHACIN DRUG WITH A PLACEBO IN DECREASING THE DEGREE TO WHICH MILD AND MODERATE ACUTE PANCREATITIS PROGRESSES TO CLINICALLY SEVERE ACUTE PANCREATITIS.
Phase 3
- Conditions
- Health Condition 1: K859- Acute pancreatitis, unspecified
- Registration Number
- CTRI/2024/05/067494
- Lead Sponsor
- Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. abdominal pain, characteristic of acute pancreatitis
2. Serum amylase or Lipase values more than three times the upper limit of normal
3. Characteristic findings of acute pancreatitis on abdominal ultrasound or CT scan.
4. Patients diagnosed with SIRS syndrome within 72 hours of admission.
5. Mild and moderate pancreatitis according to revised Atlanta classification and BISAP SCORING SYSTEM
Exclusion Criteria
1. Presence of organ failure on admission
2. Pregnancy.
3. Allergy to non-steroidal anti-inflammatory drugs.
4. Active peptic ulcer disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the change in systemic inflammatory response syndrome score(SIRS) from Admission to 48 hours & after intervention with rectal indomethacin suppositoryTimepoint: 1. at the time of admission followed by 24 hours, 48 hours & 72 hours.
- Secondary Outcome Measures
Name Time Method 1. to measure C-reactive protein levels. <br/ ><br>2. Change in SIRS scores at 24 and72 hours. <br/ ><br>3. Development of organ failure. <br/ ><br>4. Length of ICU stay. <br/ ><br>5. Length of hospitalisation. <br/ ><br>6. Acute pancreatitis SeverityTimepoint: 1. at the time of admission followed by 24 hours, 48 hours & 72 hours.