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Comparison of the effect of pidrolax, paraffin and lactulose on chronic functional constipation in children aged 2-6 years

Phase 3
Recruiting
Conditions
Chronic functional constipation.
Other constipation
K59.09
Registration Number
IRCT20211223053493N1
Lead Sponsor
Arak University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
150
Inclusion Criteria

All children with chronic constipation for at least 6 months aged 2-6 years referred to the pediatric clinic of Amirkabir Hospital
Parental consent
Do not have any disease other than constipation
Absence of any psychiatric disorders in the child or parents
No maintenance in welfare or other places than family
Not to receive constipation treatment for 2 weeks before inclusion in the study
Not being a single parent
Absence of IBS according to ROME IV criteria
Absence of mental retardation or metabolic disease (such as hypothyroidism), Hirschsprung or spinal anomalies or anorectal pathology
Absence of gastrointestinal surgery
Not to receive medical treatment affecting GI motility such as cisapride, motilium, erythromycin, loperamide

Exclusion Criteria

Lack of cooperation of parent or child
Incidence of drug side effects and severe diarrhea
Allergy to drugs

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary consequence : Number of defecation per week. Timepoint: Before starting treatment, The first week after starting treatment, Then every 2 weeks until two months later. Method of measurement: questionnaire.
Secondary Outcome Measures
NameTimeMethod
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