Evaluation of the effectiveness of olive oil topical application in infants and oral administration of Golghand (Persian traditional medicine product) by mothers on infantile colic symptoms
Evaluation of the effectiveness of olive oil topical application in infants and oral administration of Golghand by mothers on infantile colic
Design
This study is a clinical trial with control group and placebo, randomized, double-blind, and phase 2-3 on 160 patients. Patients are assigned into 4 groups of 40 by permuted block randomization method.
Settings and conduct
This study will be performed in office of a neonatal specialist. Diagnosis of infantile colic will be according to Rome IV criteria. Infants with parental consent, entry to the study and randomly assigned into 4 groups of 40 people. Blinding will be done for the outcome assessor and data analyzer by placing the allocation code in the envelope and similarity in oil container. All groups receive 5 drops of colic EZ drop in the evening and can increase to 10 drops if needed. All mothers are given a list of nutritional instructions. All parents are asked to fill a checklist daily prepared by the researcher. Variables will be evaluated and compared on days 0 and 7 and 14.
Participants/Inclusion and exclusion criteria
Inclusion criteria: term infants (gestational age more than 37 weeks) at the age of 4 to 12 weeks, birth weight more than 2500 gr; good general condition
being the first or second child of family
Exclusion criteria: infantile factors: underlying disease, malnutrition, skin lesions in the abdomen, taking antibiotics after birth, maternal factors: depression and sever stress, smoking, employment at time of study
Intervention groups
Group 1: Control
Group 2: Abdominal massage with liquid paraffin 3 times a day
Group 3: Abdominal massage with olive oil 3 times a day
Group 4: Oral consumption of Golghand by mothers 3 times a day plus abdominal massage with olive oil
Main outcome variables
Frequency of colic attacks, duration of attacks, frequency of drug use, duration of sleep and frequency of defecation during 24 hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200528047585N1
Registration date:2020-06-12, 1399/03/23
Registration timing:prospective
Last update:2020-06-12, 1399/03/23
Update count:2
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Maryam Mohamadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3502 7789
Email address
mohammadianm943@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of olive oil topical application in infants and oral administration of Golghand (Persian traditional medicine product) by mothers on infantile colic symptoms
Public title
The effect of olive oil topical aplication in infant and oral administration of Golghand by mothers in the treatment of infantile colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
term infants (gestational age more than 37 weeks)
birth weight more than 2500 gr
good general condition
Being the first or second child of family
Exclusion criteria:
Infantile underlying disease
Infant malnutrition
Skin lesions in the abdomen
Taking antibiotics after birth
Mother's depression and sever stress
Smoking by mother
Mother's employment at time of study
Age
From 28 days old to 84 days old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
permuted block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
By assigning code to each group, put the code in an opaque and closed envelope and likening the drug and placebo container (olive oil and liquid paraffin)
Placebo
Used
Assignment
Other
Other design features
In this study, the grouping method is different. Group 1 is the control group, group 2 receives massage with placebo and group 3 receives massage with the drug. Group 4 receives another intervention (oral medication for mother) in addition to massage with the drug.Therefore, this method of grouping is different from other methods.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی مشهد
Street address
Deputy of Research and Technology, Ghoreishi building, Next to the Hoveyzeh Cinema, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-02-15, 1398/11/26
Ethics committee reference number
IR.MUMS.REC.1398.300
Health conditions studied
1
Description of health condition studied
infantile colic
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
Primary outcomes
1
Description
The average duration of colic crying in 24 hours
Timepoint
0, 7 and 14 days
Method of measurement
Filling daily checklists by parents
Secondary outcomes
1
Description
Frequent colic attacks
Timepoint
0, 7 and 14 days
Method of measurement
Filling daily checklists by parents
2
Description
Duration of attacks
Timepoint
0, 7 and 14 days
Method of measurement
Filling daily checklists by parents
3
Description
Frequent use of medication
Timepoint
0, 7 and 14 days
Method of measurement
Filling daily checklists by parents
4
Description
sleep duration
Timepoint
0, 7 and 14 days
Method of measurement
Filling daily checklists by parents
5
Description
frequent of defication in 24 hours
Timepoint
0, 7 and 14 days
Method of measurement
Filling daily checklists by parents
Intervention groups
1
Description
Control group: Without intervention
Category
Treatment - Drugs
2
Description
Intervention group: Abdominal massage with placebo oil (liquid paraffin) 3 times a day
Category
Treatment - Drugs
3
Description
Intervention group: Abdominal massage with olive oil 3 times a day
Category
Treatment - Drugs
4
Description
Intervention group: Abdominal massage with olive oil 3 times a day plus Oral consumption of Golghand by mother