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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.

Comparison of rectal Indomethacin with placebo in reducing the clinical progression of mild and moderate acute pancreatitis to severe acute pancreatitis- a double blinded randomized controlled trial - NOT APPLICABLE- NO TRIAL ACRONYM

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067494
Enrollment
88
Registered
2024-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K859- Acute pancreatitis, unspecified

Interventions

Intervention1: Rectal Indomethacin Suppository: Patients with mild and moderate acute pancreatitis treated with rectal indomethacin suppositories. The patients in this arm will receive a loading dose

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Presence of organ failure on admission 2. Pregnancy. 3. Allergy to non-steroidal anti-inflammatory drugs. 4. Active peptic ulcer disease.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. to measure C-reactive protein levels. 2. Change in SIRS scores at 24 and72 hours. 3. Development of organ failure. 4. Length of ICU stay. 5. Length of hospitalisation. 6. Acute pancreatitis SeverityTimepoint: 1. at the time of admission followed by 24 hours, 48 hours & 72 hours.

Countries

India

Contacts

Public ContactDr. Vikash K

JIPMER(Jawaharlal Institute of Post graduate Medical Education and Research)

raj.jipmer@gmail.com9443292979

Outcome results

None listed

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