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Evaluation of the anti-constipation effects of abdominal application of olive oil ointment in children 1-4 years old: A double-blind, randomized clinical trial

Evaluation of the anti-constipation effects of abdominal application of olive oil ointment in children 1-4 years old: A double-blind, randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017072535304N1
Enrollment
50
Registered
2017-09-11
Start date
2017-09-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Functional constipation. Constipation

Interventions

Intervention 1: An ointment containing 85% olive oil is massaged for 5 minutes twice daily on abdominal area for two weeks. Intervention 2: An ointment containing 85% liquid paraffin (adjusted to have
Treatment - Drugs
Placebo
An ointment containing 85% olive oil is massaged for 5 minutes twice daily on abdominal area for two weeks
An ointment containing 85% liquid paraffin (adjusted to have color and odor similar to those of intervention drug) is massaged for 5 minutes twice daily on abdominal area for two weeks

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 4 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: The presence of two or more of the NASPGHAN, Rome III criteria for at least one month: Two or fewer defecations in the toilet per week At least one episode of faecal incontinence per week History of retentive posturing or excessive volitional stool retention History of painful or hard bowel movements Presence of a large faecal mass in the rectum History of large diameter stools which may obstruct the toilet. Exclusion criteria:Organic constipation, Hypothyroidism, intestinal pseudo-obstruction, cystic fibrosis, neural anomalies, intestinal obstruction, constipation-inducing medications such as calcium and iron containing supplements, anti-histamines, tricyclic antidepressants, antacids, etc.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Change in stool frequency. Timepoint: Every 3 days by pedestrician. Method of measurement: questionnaire recording stool frequency changes.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Arman Asl

School of pharmacy, Mashhad University of Medical sciences, Mashhad, Iran

armanaslh@mums.ac.ir+98 933 276 0513

Outcome results

None listed

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