Overview

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