The comparing synthetic impact of zinc and probiotic with amoxicillin in treatment of acute otitis media in children 6 months-6 years old in children,s Bandar abbas hospital 2018
The comparing synthetic impact of zinc and probiotic with amoxicillin in treatment of acute otitis media in children 6 months-6 years old in children,s Bandar abbas hospital 2018
randomized clinical trial in Bandar Abbas Children's Hospital
Participants/Inclusion and exclusion criteria
Entry Criteria:
1. Children 6 months to 6 years
2 Diagnosis of acute mediastinal otitis media: history of acute onset of symptoms with fluid in the middle ear and inflammatory symptoms (at least one of the following: 1. earache 2. intense redness of thymipan 3. thymiphanum bulimia)
Exit criteria:
1. Receiving Zinc or Probiotic
2. Chronic pulmonary or cardiac disease or immune deficiency (primary or secondary)
3. Sensitivity to zinc or phenylketonuria
4.No cooperation of parents
Intervention groups
Amoxicillin, zinc and probiotics recipients
Main outcome variables
Improvement of symptoms include pain, redness, protuberance, and type A tympanometry
General information
Reason for update
Acronym
AZPO
IRCT registration information
IRCT registration number:IRCT20180829040901N1
Registration date:2018-09-19, 1397/06/28
Registration timing:retrospective
Last update:2018-09-19, 1397/06/28
Update count:0
Registration date
2018-09-19, 1397/06/28
Registrant information
Name
Maryam Mojdeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8809 7210
Email address
mohammadbagher.rahmati@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-03-21, 1397/01/01
Trial completion date
2018-04-20, 1397/01/31
Scientific title
The comparing synthetic impact of zinc and probiotic with amoxicillin in treatment of acute otitis media in children 6 months-6 years old in children,s Bandar abbas hospital 2018
Public title
Effects of Amoxicillin, Zinc and Probiotics on Mid-Ear Infection(AOM)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 6 months to 6 years old
Diagnosis of acute mediastinal otitis media: history of acute onset of symptoms with fluid in the middle ear and inflammatory symptoms (at least one of the following: 1. earache 2. intense redness of tympan 3. tympan bulimia
Exclusion criteria:
Getting Zinc or Probiotic
Chronic pulmonary or cardiac disease or immune deficiency (primary or secondary)
Sensitization to zinc or phenylketonuria
Lack of parental cooperation
Age
From 6 months old to 6 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
126
Actual sample size reached:
94
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Bandar Abbas Children's Hospital, Daropakhsh St.,Northern Golshahr St.
City
Bandar abbas
Province
Hormozgan
Postal code
7915873665
Approval date
2018-04-29, 1397/02/09
Ethics committee reference number
IR.HUMS.REC.1397.020
Health conditions studied
1
Description of health condition studied
Acute Otitis Media
ICD-10 code
H65.0
ICD-10 code description
Acute serous otitis media
Primary outcomes
1
Description
Otitis media treatment with three drug groups
Timepoint
At the time of referral, the diagnosis of otitis media, the initiation of treatment, and then 10 days of treatment, and then the effect of treatment by examination and timpanometry
Method of measurement
Clinical examination and otoscope and timpanometry
Secondary outcomes
empty
Intervention groups
1
Description
Group one: Amoxicillin from the Farabi Pharmaceutical Company at a dose of 90-80 mg per kg daily for 10 days.
Category
Treatment - Drugs
2
Description
Intervention group 2: Zinc from Razi Pharmaceuticals received 10 mg of lentil with amoxicillin from the Farabi Pharmaceutical Company at a dose of 90-80 mg per kg of weight for ten days.
Category
Treatment - Drugs
3
Description
Intervention group 3: Probiotics (from the Nikotech Pharmaceuticals Company) receive a saccharide with amoxicillin from Farabi Pharmaceuticals at a dose of 90-80 mg per kilogram for ten days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bandar Abbas Children's Hospital
Full name of responsible person
Maryam Mojdeh
Street address
Bandar Abbas Children's Hospital, Daropakhsh St.,Northern Golshahr St.
City
Bandar abbas
Province
Hormozgan
Postal code
7915873665
Phone
+98 21 8809 7210
Email
maryam_mojdeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Farideh Hasan zadeh
Street address
Bandar Abbas Children's Hospital, Daropakhsh Avenue,Northern Golshahr Ave.
City
Bandar abbas
Province
Hormozgan
Postal code
7915873665
Phone
+98 21 8809 7210
Email
maryam_mojdeh@yahoo.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
-
Proportion provided by this source
1
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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Mojdeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Bandar Abbas Children's Hospital, Daropakhsh St,Northern Golshahr St.
City
Bandar abbas
Province
Hormozgan
Postal code
7915873665
Phone
+98 21 8809 7210
Email
maryam_mojdeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mohammad Bagher Rahmati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Bandar Abbas Children's Hospital, Daropakhsh St.,Northern Golshahr St.
City
Bandar Abbas
Province
Hormozgan
Postal code
7915873665
Phone
+98 76 3366 6240
Email
mbrahmati@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Mojdeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Bandar Abbas Children's Hospital, Daropakhsh St.,Northern Golshahr St..
City
Bandar abbas
Province
Hormozgan
Postal code
7915873665
Phone
+98 21 8809 7210
Email
maryam_mojdeh@yahoo.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
The total potential data can be shared after being unidentified.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Any analysis on the delivered data is allowed.
From where data/document is obtainable
mbrahmati@yahoo.com
00989177615397
Dr. mohammad bagher rahmati
What processes are involved for a request to access data/document
Time to access file and documentation for about a year