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
Constipation is the most prevalence gastrointestinal disease in children with prevalence of 0.8-25%. In Traditional Persian Medicine, medicinal plants play an important role in the treatment of constipation. Among them, oral use and topical application of olive oil has been widely recommended. In the present study, children 1-4 years of age which have been diagnosed with functional constipation according NASPGHAN, Rome III criteria were included for two weeks. The patients were randomly divided into two groups. The intervention group received an ointment containing 85% olive oil two times daily. The placebo group received an ointment containing 85% of liquid paraffin whose color and smell were adjusted to be similar to that of intervention ointment. Both ointments were applied on abdominal area with circular massage for 5 minutes. The application method was taught to children's caregivers. Patients are being visited by Pediatric specialist every three days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072535304N1
Registration date:2017-09-11, 1396/06/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-11, 1396/06/20
Registrant information
Name
Hossein Arman asl
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51331801
Email address
armanaslh911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research council, Mashhad University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 1 year old to 4 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Committee for Research Ethics, Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
91775-1365
Approval date
2017-05-24, 1396/03/03
Ethics committee reference number
IR.MUMS.fm.REC.1396.43
Health conditions studied
1
Description of health condition studied
Functional constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
change in stool frequency
Timepoint
Every 3 days by pedestrician
Method of measurement
questionnaire recording stool frequency changes
Secondary outcomes
empty
Intervention groups
1
Description
An ointment containing 85% olive oil is massaged for 5 minutes twice daily on abdominal area for two weeks
Category
Treatment - Drugs
2
Description
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
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Hossein Arman Asl
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
School of pharmacy, Pardis university campus, Park square
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of pharmacy, Mashhad University of Medical sciences, Mashhad, Iran
Full name of responsible person
Hossein Arman Asl
Position
Pharm.D. student
Other areas of specialty/work
Street address
School of pharmacy, Pardis university campus, Park square
City
Mashhad
Postal code
Phone
+98 933 276 0513
Fax
Email
armanaslh@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical sciences, Mash
Full name of responsible person
Behjat Javadi
Position
Assistant professor/ Pharm.D; Ph.D
Other areas of specialty/work
Street address
School of Pharmacy, Pardis University Campus, Park Square
City
Mashhad
Postal code
Phone
+98 51 3180 1268
Fax
Email
javadib@mums.ac.ir; behjat.javadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Hossein Arman Asl
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)