Evaluation the effect of abdominal massage with Mastic gum oil on the symptoms of gastroesophageal reflux disease in children 2month-1year compared to abdominal massage without oil.
-Comparison of the effect of abdominal massage with and without mastic gum oil on the severity and frequency of vomiting،crying and restlessness while breastfeeding of Gastroesophageal reflux disease in children from 2 months to 1 years.
.- Comparison of the effect of abdominal massage with and without mastic gum oil on the Symptoms recurrence of Gastroesophageal reflux disease in children from 2 months to 1 years.
Design
Clinical trials with community-based and pragmatic control group, with parallel groups, without blindness, randomized
Settings and conduct
Listed 90 patients with gastro-oesophageal reflux who have entered the research criteria from the Hazrat Ali Asghar Hospital
GSQ-I questionnaire completed and randomly divided into 2 groups of 45 people
Participants/Inclusion and exclusion criteria
Children aged 2 months to 1 year referred to the clinic of Ali Asghar Hospital
Diagnosis of GERD according to GSQ-I questionnaire and Pediatric gastroenterologist
Not having other serious gastrointestinal diseases, such as esophagitis, achalasia, gastrointestinal ulcers, inflammatory diseases of the gastrointestinal tract, etc. According to the pediatric gastroenterologist
،History of allergy or skin allergy to the drug or herbal compounds
Allergy to cow's milk protein
Intervention groups
Intervention group is received omeprazole capsules and abdominal masage with mastic gum oil. Omeprazole (Abidi®) will be prescribed 1 mg/kg/day in 2 divided Dose, 15 min before child feedingAbdominal massage is performed 10-15 minutes every 12 hours, half an hour after eating milk or auxiliary food،
The treatment will last for two weeks.
The control group will receive omeprazole capsules and abdominal massage without oil.
Main outcome variables
Severity and frequency of vomiting, crying and restlessness, during the last 7 days,Recurrence symptoms one week and 4 weeks after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180406039204N1
Registration date:2018-05-16, 1397/02/26
Registration timing:registered_while_recruiting
Last update:2018-05-16, 1397/02/26
Update count:0
Registration date
2018-05-16, 1397/02/26
Registrant information
Name
Mansureh Akhavan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8861 7545
Email address
akhavan.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-10, 1397/02/20
Expected recruitment end date
2019-05-10, 1398/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of abdominal massage with Mastic gum oil on the symptoms of gastroesophageal reflux disease in children 2month-1year compared to abdominal massage without oil.
Public title
Evaluation the effect of abdominal massage with Mastic gum oil on the reflux disease in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children more than two months and less than 1 years old in aliasghar hospital
Diagnosis of GERD on the basis of GSQ-I questionnaire and pediatric gastroenterologist
Absence of serious gastrointestinal diseases such as esophagitis, achalasia, gastrointestinal ulcers, IBD (Inflamatory Bowel disease),….
Exclusion criteria:
History of allergy or skin allergy to the drug or herbal compounds
Allergy to cow's milk protein
Infants with a history of gastrointestinal surgery and neurological disease, liver, kidney, or history of severe cardio-pulmonary disease, as well as history of peptic ulcer
Guardian to cooperate in filling the forms (cognitive or language disorder).
Age
From 2 months old to 1 year old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization Based on random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The abdominal massage is performed rotated and clockwise
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Fifth Floor, Headquarters, Hemet Highway Between Chamran and Sheikh Fazlullah, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-02-25, 1396/12/06
Ethics committee reference number
IR.IUMS.REC1396.9421309001
Health conditions studied
1
Description of health condition studied
Gastroesophageal reflux
ICD-10 code
K21
ICD-10 code description
Gastro-esophageal reflux disease
Primary outcomes
1
Description
Severity of css index
Timepoint
At the beginning of the study, 14 days after the intervention and 7، 28 days after discontinuation of treatment
Method of measurement
GSQ-I questionnaire
2
Description
Severity and frequency of vomiting
Timepoint
At the beginning of the study, 14 days after the intervention and 7، 28 days after discontinuation of treatment
Method of measurement
GSQ-I questionnaire
3
Description
Severity and frequency of crying and restlessness while breastfeeding
Timepoint
At the beginning of the study, 14 days after the intervention and 7، 28 days after discontinuation of treatment
Method of measurement
GSQ-I questionnaire
Secondary outcomes
1
Description
side efect
Timepoint
Any time during the study
Method of measurement
Report by the child's supervisor
2
Description
Time Control Signs
Timepoint
Any time during the study
Method of measurement
Report by the child's supervisor
3
Description
Recurrence of symptoms
Timepoint
7 and 28 days after discontinuation of treatment
Method of measurement
Report by the child's supervisor
Intervention groups
1
Description
Intervention group:Omeprazole capsule and abdominal massage with mastic gum oil.Omeprazole (Abidi®) will be prescribed 1 mg/kg/day in1 Dose,Fasting morning before child feeding .Abdominal massage with mastic gum oil every 12 hours, half an hour after milking or supplements.Duration of treatment is 2 weeks
Category
Treatment - Drugs
2
Description
Control group: Omeprazole capsule and abdominal massage without oil.Omeprazole (Abidi®) will be prescribed 1 mg/kg/day in1 Dose,Fasting morning before child feeding .Abdominal massage every 12 hours, half an hour after milking or supplements.Duration of treatment is 2 weeks
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
mansooreh akhavan
Street address
Ali Asghar Hospital ,zafar street.shariati street
City
tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2222 2041
Email
akhavan.m@tak.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
D.mazaher negad
Street address
Islamic Medicine and Supplement , Institute of Medical History Studies, No. 9, Pirnia Alley, Laleh Zar North Street (Laleh Zar Nou), Islamic Republic. Street,
City
tehran
Province
Tehran
Postal code
۱۱۴۵۸۴۷۱۱۱
Phone
+98 21 3395 0152
Email
imhicmr@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
mansooreh akhavan
Position
Iranian medical resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine, 847,Behesht Street,South side of Park City,Vahdat-e-Islami St.,, Hassan Abad Square,tehran
City
tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5558 0388
Email
stm@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
hooreh mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine, 847,Behesht Street,South side of Park City,Vahdat-e-Islami St.,, Hassan Abad Square,tehran
City
tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5515 2192
Email
hmk1358@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
mansureh akhavan
Position
Iranian medical resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine, 847,Behesht Street,South side of Park City,Vahdat-e-Islami St.,, Hassan Abad Square,tehran
City
tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5558 0388
Email
akhavan.m@tak.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available