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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

May 27, 2022

Primary Completion Date

July 20, 2023

Study Completion Date

July 22, 2023

Conditions
Anal FissureConstipation
Interventions
DRUG

Polyethylene Glycol

Patients will be advised Anobliss (lidocaine with nifedipine) ointment for local application in the anal canal for one month for relief of pain and anal sphincter spasm. Polyethylene glycol syrup at a dose of 15-30 ml will be used for 2 weeks for relief of acute constipation. Patients will be assessed at 1 week and 1 month and evaluated for primary and secondary outcomes.

DRUG

Isabgol + Lactulose

Patients will be advised Anobliss (lidocaine with nifedipine) ointment for local application in the anal canal for one month for relief of pain and anal sphincter spasm. Isabgol husk at a dose of 2 teaspoons in 200 ml of warm water before bedtime and 30 ml of syrup lactulose at bedtime will be used for 2 weeks for relief of acute constipation. Patients will be assessed at 1 week and 1 month and evaluated for primary and secondary outcomes.

Trial Locations (1)

751019

All India Institute of Medical Sciences, Bhubaneswar

All Listed Sponsors
lead

All India Institute of Medical Sciences, Bhubaneswar

OTHER