drugset / Trial / NCT05341180

Efficacy of Polyethylene Glycol vs Lactulose With Isabgol in Acute Fissure-in-Ano: PEGASIS Trial

NCT05341180

Phase 2/3 Completed 144 enrolled All India Institute of Medical Sciences, Bhubaneswar
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2022-05-27
Primary completion
2023-07-20
Completion
2023-07-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Isabgol Unknown Oral
Comparator Lactulose Other / unclassified 30 ml Oral
Comparator polyethylene glycol Other / unclassified 15 ml Oral
Comparator polyethylene glycol Other / unclassified 30 ml Oral

Indications