NCT05341180

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 27, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

April 10, 2022

Last Update Submit

July 21, 2023

Conditions

Anal FissureConstipation

Keywords

Acute fissure in anoConstipationLactuloseIsabgolPolyethylene Glycol

Outcome Measures

Primary Outcomes (1)

  • Time taken for the resolution of acute pain following fissure in ano.

    Pain will be measured by improvement in visual analog scale (VAS) pain score. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 10).

    30 days

Secondary Outcomes (3)

  • Improvement in constipation will be assessed by a change in the Bristol stool form scale.

    1 week, 1 month

  • Adverse effects any of PEG or lactulose with isabgol.

    1 month

  • Patient compliance with the medications

    1 month

Study Arms (2)

Study group 1(Polyethylene Glycol)

ACTIVE COMPARATOR

Polyethylene glycol syrup will be used at a dose of 15-30 ml per day for 2 weeks maximum.

Drug: Polyethylene Glycol

Study group 2 (Isabgol and Lactulose)

ACTIVE COMPARATOR

Isabgol 2 teaspoons in 200ml of warm water to consume immediately after soaking before bedtime and syrup Lactulose 30 ml at bedtime for 2 weeks.

Drug: Isabgol + Lactulose

Interventions

Polyethylene GlycolDRUG

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.

Also known as: Freego PEG oral solution from Alembic Pharmaceuticals Ltd.
Study group 1(Polyethylene Glycol)
Isabgol + LactuloseDRUG

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.

Also known as: Duphalac oral solution from Abbott
Study group 2 (Isabgol and Lactulose)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

Bhubaneswar, Odisha, 751019, India

Location

Related Publications (5)

  • Lee-Robichaud H, Thomas K, Morgan J, Nelson RL. Lactulose versus Polyethylene Glycol for Chronic Constipation. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007570. doi: 10.1002/14651858.CD007570.pub2.

    PMID: 20614462BACKGROUND

  • Wang HJ, Liang XM, Yu ZL, Zhou LY, Lin SR, Geraint M. A Randomised, Controlled Comparison of Low-Dose Polyethylene Glycol 3350 plus Electrolytes with Ispaghula Husk in the Treatment of Adults with Chronic Functional Constipation. Clin Drug Investig. 2004;24(10):569-76. doi: 10.2165/00044011-200424100-00002.

    PMID: 17523718BACKGROUND

  • Tomatsu S, Dieter T, Schwartz IV, Sarmient P, Giugliani R, Barrera LA, Guelbert N, Kremer R, Repetto GM, Gutierrez MA, Nishioka T, Serrato OP, Montano AM, Yamaguchi S, Noguchi A. Identification of a common mutation in mucopolysaccharidosis IVA: correlation among genotype, phenotype, and keratan sulfate. J Hum Genet. 2004;49(9):490-494. doi: 10.1007/s10038-004-0178-8. Epub 2004 Aug 11.

    PMID: 15309681BACKGROUND

  • Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.

    PMID: 22336789BACKGROUND

  • Belsey JD, Geraint M, Dixon TA. Systematic review and meta analysis: polyethylene glycol in adults with non-organic constipation. Int J Clin Pract. 2010 Jun;64(7):944-55. doi: 10.1111/j.1742-1241.2010.02397.x.

    PMID: 20584228BACKGROUND

MeSH Terms

Conditions

Fissure in AnoConstipation

Interventions

Polyethylene GlycolsLactulose

Condition Hierarchy (Ancestors)

Anus DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Prakash Kumar Sasmal, MBBS, MS

    Department of General Surgery, All India Institute of Medical Sciences, Bhubaneswar, Odisha, INDIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional Professor, Department of General Surgery

Study Record Dates

First Submitted

April 10, 2022

First Posted

April 22, 2022

Study Start

May 27, 2022

Primary Completion

July 20, 2023

Study Completion

July 22, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)