Efficacy of Polyethylene Glycol vs Lactulose With Isabgol in Acute Fissure-in-Ano: A RCT (PEGASIS Trail)

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The existing literature stresses the better efficacy of polyethylene glycol (PEG) over other stool softeners like lactulose or isabgol to improve functional constipation.

But there is no consensus regarding the efficacy of PEG alone vs lactulose combined with isabgol used as stool softeners, frequently used for relieving acute constipation in an acute fissure in ano. Hence a good quality randomised study to compare both efficacies is the need of the hour.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar
• Treatments: Lactulose; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• All patients presenting with acute fissure in ano between the age group of 18 to 75 years.

Exclusion Criteria:

• Pregnancy / lactation

• Patients not giving consent

• Patients not able to understand the nature of the study

• Diabetes mellitus and chronic kidney disease

• Known intolerance to PEG/Lactulose or Isabgol

• Prior enrolment in other study.

• Patient undergoing surgery for Fissure in Ano