The aim of this study is to determine the effect of Rosa Damascena Extract in the treatment and eradication of asymptomatic Helicobacter Pylori infection in children 9 to 15 years old of Birjand.The sample of this study is 200 people including 100 cases and 100 control subjects. The main inclusion criteria of this study are age between 9 to 15 years old and being a resident of Birjand. The main exclusion criteria are gastrointestinal symptoms requiring treatment, antibiotic use in the last month, taking antacids, diarrhea, immunodeficiency and food and drug allergy. The study duration is 6 months that during this period the case group will be treated with Rosa Damascena Extract (as the studying intervention) and the control group will receive a mixture of starch and sugar as a placebo. Before and after the intervention stool samples study for the presence of H.pylori antigens on all patients will be carried out in order to monitor the outcome of the study (quantitative amount of Helicobacter pylori antigen in stool).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052328012N1
Registration date:2016-12-23, 1395/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-23, 1395/10/03
Registrant information
Name
Hadi Moulaei
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 32433001
Email address
moulaei.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2016-09-10, 1395/06/20
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Rosa Damascena Extract in treatment and eradication of asymptomatic Helicobacter pylori infection in children
Public title
Effect of Rosa Damascena Extract in treatment and eradication of asymptomatic Helicobacter pylori infection in 9-15 years old children of Birjand
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 9 to 15 years old; Residence of Birjand; Consent to participate in the study Exclusion criteria: unwillingness to participate; gastrointestinal signs that require treatment; use of antibiotics in last month; taking antacids drugs (PPI and H2blocker); diarrhea; immunodeficiency; food and drug allergy.
Age
From 9 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Moalem Blvd
City
Birjand
Postal code
9717853577
Approval date
2016-04-27, 1395/02/08
Ethics committee reference number
ir.bums.1395.7
Health conditions studied
1
Description of health condition studied
Helicobacter Pylori Infection
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
Primary outcomes
1
Description
Quantitative amount of Helicobacter pylori antigen in stool sample
Timepoint
before intervention - after intervention
Method of measurement
Laboratory result
Secondary outcomes
empty
Intervention groups
1
Description
Case (intervention) group: after training on drug consumption and emphasis on contact the physician if confronted with drug side effects, they will treated with Rosa Damascena Extract with 20 mg daily per kilogram twice a day for 14 days.
Category
Treatment - Drugs
2
Description
Control group will treated with placebo (a mixture of starch and sugar), for 14 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Elemetary and High schools of Birjand City
Full name of responsible person
Dr. Hadi Moulaei
Street address
Moallem Blvd
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research - Birjand University of Medical Sciences
Full name of responsible person
Doctor Zarban
Street address
Moallem Blvd
City
Birjand
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 - Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Hadi Moulaei
Position
Resident of Pediatrics
Other areas of specialty/work
Street address
Valiasr hospital, Ghafari street
City
Birjand
Postal code
9717853577
Phone
+98 56 3244 3000
Fax
+98 32430076
Email
moulaei.h@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Kokab Namakin
Position
Associate Professor
Other areas of specialty/work
Street address
Valiasr hospital, Ghafari street
City
Birjand
Postal code
9717853577
Phone
+98 51 3244 3045
Fax
+98 32430076
Email
namakin@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Hadi Moulaei
Position
Resident of Pediatrics
Other areas of specialty/work
Street address
Valiasr hospital, Ghafari street
City
Birjand
Postal code
9717853577
Phone
+98 56334430000
Fax
+98 32430076
Email
moulaei.h@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)