Investigation of the effect of appliance of dietary interventions based on Persian medicine by nursing mothers on infantile gastroesophageal reflux
Design
In this research, 84 eligible patients referring to Persian Medicine Center of Shahed University or Aliasghar subspecialty hospital for children were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
Center of Study: Persian Medicine Center of Shahed University and Aliasghar subspecialty hospital for children; Method Of Study: In first clinical visit mothers of intervention group will receive dietary interventions based on Persian Medicine which breastmilk correction is gold consept, also lifestyle modification about infantile GER will be taught to both intervention and control group, these interventions must apply for 4 weeks, then at the end of 2nd week (through phone contact), the end of 4th week (through clinical visit) and the end of 6th week (through phone contact) frequency and severity of signs and symptoms of reflux will be assessed; in this study all interventions will be secret from mothers of both groups and appointment days will separate for participant of each group
Participants/Inclusion and exclusion criteria
Inclusion criteria : Infants under 5 months old with mild to moderate infantile GER which the diagnosis is confirmed by the pediatric gastroenterologist; Exclusion criteria: Any significant medical or surgical disease of mother or infant; Necessity of medical treatment for infantile GER at the bigining or duration of the study; Other types of gastrointestinal diseases such as esophagitis, peptic ulcer ,etc
Intervention groups
Intervention group: In first clinical visit mothers will receive dietary interventions which is based on Persian Medicine, also in order to keep the infants from being absent of classical medicine treatment mothers is being taught about infantile reflux lifestyle modification;
Control group: In first clinical visit in order to keep the infants from being absent of classical medicine treatment mothers is being taught about infantile reflux lifestyle modification
Main outcome variables
Assessment and comparison of frequency of signs and symptoms of infantile GER in both groups: in 2nd, 4th and 6th week; Assessment and comparison of severity of signs and symptoms of infantile GER in both groups: in 2nd, 4th and 6th week;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170701034828N1
Registration date:2017-12-28, 1396/10/07
Registration timing:registered_while_recruiting
Last update:2017-12-28, 1396/10/07
Update count:0
Registration date
2017-12-28, 1396/10/07
Registrant information
Name
Maryam Jahangir
Name of organization / entity
Department of Persian Medicine, School of Medicine, Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 4056
Email address
m.jahangir@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahed University
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of appliance of dietary interventions based on Persian medicine by nursing mothers on infantile gastroesophageal reflux.
Public title
Effect of dietary interventions based on Persian medicine on infantile gastroesophageal reflux.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants under 5 months old (girls and boys)
Exclusive breastfeeding
Clinically confirmation of infantile GER by the pediatric gastroenterologist
Score of Gastroesophageal Reflux Questionnair - Infantile (GSQ-I questionnaire) above 16 (the min score for confirm GER)
Exclusion criteria:
Any diagnosed disease of mother or infant that needs medical or surgical therapy
Any other type of gastrointestinal disease such as hiatal hernia, erosive esophagitis, etc in infants
Necessity of medical treatment for infantile reflux at the bigining or through the study
Any diagnosed disease of mother or infant that due to it breastfeeding is forbidden
Any consumption of effective medicine on GER in infants, such as Proton pump inhibitors, H2-receptor antagonists, etc
Age
To 5 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is permuted block randomization. Each unit of randomization is a person.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a single binde trial, which participents are not aware of the two intervention methods.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed University, Ethics Committee on Biomedical Research
Street address
Shahed University, Front of Imam Khomeini holy shrine, Persian Gulf freeway (Tehran-Qom), Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2017-08-27, 1396/06/05
Ethics committee reference number
IR.Shahed.REC.1396.30
Health conditions studied
1
Description of health condition studied
Infantile Gastroesophageal Reflux
ICD-10 code
P78.8
ICD-10 code description
Other specified perinatal digestive system disorders
Primary outcomes
1
Description
Frequency of Infantile Gastroesophageal Reflux signs
Timepoint
Before intervention, 2 weeks after intervention, the end of intervention (4th week), 6th week
Method of measurement
GERD Symptoms Questionnaire for infants (GSQ-I)
2
Description
Severity of Infantile Gastroesophageal Reflux signs
Timepoint
Before intervention, 2 weeks after intervention, the end of intervention (4th week), 6th week
Method of measurement
GERD Symptoms Questionnaire for infants (GSQ-I)
Secondary outcomes
1
Description
Infant weight
Timepoint
Before intervention, The end of intervention (4th week)
Method of measurement
Baby scale, Gramme
2
Description
Infant height
Timepoint
Before intervention, The end of intervention (4th week)
Method of measurement
Measuring board, centimeter
3
Description
Nursing mothers' gastric temperament
Timepoint
Before intervention, The end of intervention (4th week)
Method of measurement
Gastric temperament check list
Intervention groups
1
Description
Intervention 1 (Intervention Group) : Dietary interventions based on Persian medicine will be presented to nursing mothers of this group in 1 session (1st clinical visit) as face to face teaching by executor of plan, and the written guidance paper will be
Category
Lifestyle
2
Description
Intervention 2 (Control Group): Classic medicine’s standard treatment strategy of mild to moderate infantile GERD which is about lifestyle modifications and breastfeeding pattern, will be presented to control group. So these infants are not being deprived
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center of Iranian Traditional Medicine of shahed University
Full name of responsible person
Maryam Jahangir
Street address
Shahid Jafari Alley, 3rd Dashtestan Alley, lower than Hosseiniye-e-ershad, Shariati st, Tehran
City
Tehran
Province
Tehran
Postal code
1947948311
Phone
+98 21 2288 2521
Fax
+98 21 2288 2596
Email
info@timclinic.ir
Web page address
http://www.timclinic.ir/
2
Recruitment center
Name of recruitment center
Aliasghar Children's Hospital
Full name of responsible person
Dr. Shahrbanoo Nakhaee
Street address
Aliasghar Children's Hospital, Shahid Dastgerdi St (Zafar), Ayatollah madarres Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1919816766\
Phone
+98 21 2222 2041
Email
aach@iums.ac.ir
Web page address
http://www.aac-hospital.com/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahed University
Full name of responsible person
Dr. Zahra Kiasalari
Street address
Vice chancellor for research, Shahed University, Front of Imam Khomeini holy shrine, Persian Gulf freeway (Tehran-Qom), Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5105
Email
info@shahed.ac.ir
Web page address
http://shahed.ac.ir/research/Pages/Home.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahed University
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
Department of Persian Medicine, School of Medicine, Shahed University
Full name of responsible person
Maryam Jahangir
Position
Ph.D student of Persian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shahed University, Front of Imam Khomeini holy shrine, Persian Gulf freeway (Tehran-Qom), Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4055
Fax
+98 21 5121 4056
Email
m.jahangir@shahed.ac.ir
Web page address
http://shahed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Persian Medicine, School of Medicine, Shahed University
Full name of responsible person
Dr. Elham Emaratkar
Position
Persian Medicine Specialist, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shahed University, Front of Imam Khomeini holy shrine, Persian Gulf freeway (Tehran-Qom), Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4055
Fax
+98 21 5121 4056
Email
e.emaratkar@gmail.com
Web page address
http://shahed.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Department of Persian Medicine, School of Medicine, Shahed University
Full name of responsible person
Maryam Jahangir
Position
Ph.D. student of Persian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shahed University, Front of Imam Khomeini holy shrine, Persian Gulf freeway (Tehran-Qom), Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4055
Fax
+98 21 5121 4056
Email
m.jahangir@shahed.ac.ir
Web page address
http://shahed.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