Comparative study of the effect of abdominal massage with rose oil and olive oil on the symptoms of Gastroesophagal reflux disease in pediatrics aged 2 months to 1 year
Design
Two arm parallel group triple-blind randomized clinical trial
Settings and conduct
Patients are divided into two groups. For the first group, in addition to the usual treatment, abdominal massage with rose oil in the base of olive oil (every 12 hours) and for the second group, in addition to routine treatment, abdominal massage with olive oil (every 12 hours) is prescribed. Patients will be monitored weekly for the effect of the drug on clinical symptoms and its possible complications.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children 2 months to 1 year referred to Ali Asghar Hospital Clinic
Diagnosis of GERD based on GSQ-I questionnaire by pediatric gastroenterologist
Exclusion criteria:
Serious gastrointestinal diseases such as esophagitis, achalasia, gastrointestinal ulcers, inflammatory gastrointestinal diseases
A history of allergy to herbal ingredients
Allergy to cow milk protein
History of gastrointestinal surgery
History of liver, kidney, neurologic or severe cardiopulmonary diseases
Inability of parents to cooperate in filling out the forms (mental disorders or language problems)
Intervention groups
90 patients with gastroesophageal reflux who meet the inclusion criteria are selected and divided into two groups randomly.For the first group, in addition to the usual treatment, abdominal massage with Rose oil at the base of the olive oil (every 12 hours), and for the second group, in addition to the usual treatment, abdominal massage with olive oil(every 12 hours) is prescribed. The effects and complications of drug will be monitored weekly.
Main outcome variables
Vomiting; Crying and restlessness during breast feeding; Side effects; Symptom control time; Symptom recurrence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191216045752N1
Registration date:2020-01-28, 1398/11/08
Registration timing:registered_while_recruiting
Last update:2020-01-28, 1398/11/08
Update count:0
Registration date
2020-01-28, 1398/11/08
Registrant information
Name
maryam moghimi
Name of organization / entity
Masiha Teb Shomal Knowledge-based cooperation
Country
Iran (Islamic Republic of)
Phone
+98 21 6676 5787
Email address
baran10mordad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of abdominal massage with rose oil and olive oil on the symptoms of Gastroesophagal reflux disease in pediatrics
Public title
Comparative study of the effect of abdominal massage with rose oil and olive oil on the symptoms of Gastroesophagal reflux disease in pediatrics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 2 months to 1 year referred to Ali Asghar Hospital Clinic
Diagnosis of GERD based on GSQ-I questionnaire by pediatric gastroenterologist
Exclusion criteria:
serious gastrointestinal diseases such as esophagitis, achalasia, gastrointestinal ulcers, inflammatory gastrointestinal diseases
A history of allergy to herbal ingredients
Allergy to cow milk protein
History of gastrointestinal surgery
History of liver, kidney, neurologic or severe cardiopulmonary diseases
Inability of parents to cooperate in filling out the forms (mental disorders or language problems)
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
The presenter divides the participants into two groups according to the severity of the disease and refers them to the secretary of the ward.Two series of randomized blocks for severely and moderately ill patients are already provided to the secretary, in which letters A and B are written in unspecified sequences.Depending on the severity of the disease, the secretary selects one of these groups for the patient and gives him/her the appropriate drug.The drugs, which are almost similar in color and smell, are packed in 60cc containers and given to the secretary who is unaware of the contents of the container.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The presenter divides the participants into two groups according to the severity of the disease and refers them to the secretary of the ward.Two series of randomized blocks for severely and moderately ill patients are already provided to the secretary, in which letters A and B are written in unspecified sequences.Depending on the severity of the disease, the secretary selects one of these groups for the patient and gives him/her the appropriate drug.The drugs, which are almost similar in color and smell, are packed in 60cc containers and given to the secretary who is unaware of the contents of the container.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran university of medical sciences
Street address
Hemat highway, next to Milad tower
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-11-04, 1398/08/13
Ethics committee reference number
IR.Iums.rec.1398.799
Health conditions studied
1
Description of health condition studied
gastroesophageal reflux (GERD)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The intensity and frequency of vomiting during the past 7 days
Timepoint
Weeks 1, 2, 3 and 4 during the intervention and weeks 1 and 4 after the intervention
Method of measurement
Asking parents
2
Description
Time to control symptoms
Timepoint
Weeks 1, 2, 3 and 4 during the intervention and weeks 1 and 4 after the intervention
Method of measurement
Asking parents
Secondary outcomes
1
Description
Crying and restlessness while breastfeeding
Timepoint
Weeks 1, 2, 3 and 4 during the intervention and weeks 1 and 4 after the intervention
Method of measurement
Asking parents
2
Description
side effects
Timepoint
Weeks 1, 2, 3 and 4 during the intervention and weeks 1 and 4 after the intervention
Method of measurement
Asking parents
Intervention groups
1
Description
Intervention group: Infants from 2 months to 1 year of age with gastroesophageal reflux of the first group, in addition to the usual treatment, are given an abdominal massage with rose oil (in the base of olive oil) every 12 hours. For greater effectiveness, a topical abdominal massaging method is chosen, with 1-5 drops per 10-15 minutes based on birth months.
Category
Treatment - Drugs
2
Description
Intervention group: Infants from 2 months to 1 year of age with gastroesophageal reflux of the second group, in addition to the usual treatment, are given an abdominal massage with olive oil every 12 hours. For greater effectiveness, a topical abdominal massaging method is chosen, with 1-5 drops per 10-15 minutes based on birth months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar hospital
Full name of responsible person
Hoorieh mohammadi kenari
Street address
Vahid Dastgerdi Ave., Modarres highway
City
tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2222 2041
Email
aach@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Amir Hosein Jamshidi
Street address
No.748, Behesht street, Vahdat eslami Ave., Hasan Abad Sq.
City
tehran
Province
Tehran
Postal code
114733311
Phone
+98 21 5558 0388
Email
stm@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Islamic and Complementary Medicine
Proportion provided by this source
100
Public or private sector
Public
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
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Hoorieh mohammadi Kenari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.748, Behesht street, Vahdat eslami Ave., Hasan Abad Sq.
City
Tehran
Province
Tehran
Postal code
114733311
Phone
+98 21 5558 0388
Email
mohammadikenari.h@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Hoorieh mohammadi Kenari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.748, Behesht street, Vahdat eslami Ave., Hasan Abad Sq.
City
Tehran
Province
Tehran
Postal code
114733311
Phone
+98 21 5558 0388
Email
mohammadikenari.h@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Masiha Teb Shomal Knowledge-based cooperation
Full name of responsible person
Maryam Moghimi
Position
Medical doctor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.79, Razi street, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1133733414
Phone
+98 21 6676 5787
Fax
Email
baran10mordad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
This will be mentioned in the article method.
When the data will become available and for how long
This will be mentioned in the article method.
To whom data/document is available
This will be mentioned in the article method.
Under which criteria data/document could be used
This will be mentioned in the article method.
From where data/document is obtainable
This will be mentioned in the article method.
What processes are involved for a request to access data/document