Skip to content

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

Comparison of the effect of pidrolax, paraffin and lactulose on chronic functional constipation in children aged 2-6 years referred to the pediatric clinic of Amirkabir Hospital

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211223053493N1
Enrollment
150
Registered
2022-04-27
Start date
2022-04-04
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic functional constipation. Other constipation

Interventions

Intervention 1: Intervention group: Intervention group 1: In Pidrolax group, the child is given 0.7 g / kg body weight (Sepidaj Pharmaceutical Company, Iran) orally in the morning fasting. Interventio

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary consequence : Nausea. Timepoint: Before starting treatment, The first week after starting treatment, Then every 2 weeks until two months later. Method of measurement: questionnaire.;Secondary consequence : Stool consistency. Timepoint: Before starting treatment, The first week after starting treatment, Then every 2 weeks until two months later. Method of measurement: questionnaire.;Secondary consequence : Number of abdominal pains 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 consequence : Number of painful bowel movements 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 consequence : Anorexia. Timepoint: Before starting treatment, The first week after starting treatment, Then every 2 weeks until two months later. Method of measurement: questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mojtaba Hashemi

Arak University of Medical Sciences

mojtaba53hashemi@yahoo.com+98 86 3313 4715

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026