This is an outpatient, double-blind and randomized clinical trial study to compare the effects of Cydonia oblonga syrup with Omeprazole syrup in children aged 1 months to 18 years old with symptomatic gastroesophageal reflux disease. 80 patients after getting informed consent signed by the parent / guardian, will be accepted. They are according to the instructions North American Society for
Pediatric Gastroenterology, Hepatology, and Nutrition for gastroesophageal reflux disease and supervision of a pediatric gastroenterologist, will be selected. They will allocate to two arms using block randomization. Drugs will be encoded and prescribe 2 times a day for 4 weeks. Patients will evaluating by the age specific questionnaire for gastroesophageal reflux disease symptoms for 7 weeks (2 weeks post-treatment).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030921388N1
Registration date:2015-05-16, 1394/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-16, 1394/02/26
Registrant information
Name
Mohammad Ebrahim Zohalinezhad
Name of organization / entity
Shiraz University of Medical scineces
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 7589
Email address
zohalinm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical sciences
Expected recruitment start date
2015-02-09, 1393/11/20
Expected recruitment end date
2015-05-10, 1394/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial study in treatment of children with gastroesophageal reflux disease symptoms: Cydonia oblonga syrup versus omeprazole syrup
Public title
The evaluation of effectiveness of "Cydonia oblonga syrup" on clinical symptoms in patients with Gastroesophageal reflux disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children more than one month and less than 18 years old; signed an informed consent form by parents; Vomiting immediately after eating; restlessness for one to three hours after feeding; respiratory distress after feeding; the lack of weight gain; refusing to eat; endoscopically proven gasteroeshophageal reflux disease.
Exclusion criteria: Children younger than 1 month and older than 18 years old; those who need to use other oral or intravenous drugs; unwillingness to continue to participate in the study; sensitivity to study drugs; patients with other gasteroeshophageal disorders such as esophagitis and peptic ulcer; patients with active renal, liver and neurological diseases; mental retardation; pregnancy; lactation and disability of parents/guardian to cooperate in filling the forms (cognitive or language disorder).
Age
From 1 month old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand Ave.
City
Shiraz
Postal code
Approval date
2015-02-08, 1393/11/19
Ethics committee reference number
CT-9370-7360
Health conditions studied
1
Description of health condition studied
Pediatric gastro-oesophageal reflux disease
ICD-10 code
K21.9
ICD-10 code description
Gastro-oesophageal reflux disease without oesophagitis
Primary outcomes
1
Description
Vomiting/regurgitation episodes
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
2
Description
Severity of Vomiting/regurgitation
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
3
Description
Refusal of feed episodes
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
4
Description
Severity of feed refusal
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
5
Description
Irritability/Fussiness episodes
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
6
Description
Severity of Irritability/Fussiness
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
7
Description
Hiccup/Belching episodes
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
8
Description
Severity of hiccup/belching
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
9
Description
Choking when eating episodes
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
10
Description
Severity of Choking when eating
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
11
Description
Arching back episodes
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
12
Description
Severity of arching back
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
13
Description
Abdominal pain episodes
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
14
Description
Severity of abdominal pain
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
15
Description
Nausea episodes
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
16
Description
Severity of nausea
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
17
Description
Chest pain/ Heart burn episodes
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
18
Description
Severity of chest pain/ heart burn
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
19
Description
Difficulty swallowing episodes
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
20
Description
Severity of difficulty swallowing
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
21
Description
Pain after eating episodes
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
22
Description
Severity of pain after eating
Timepoint
Weekly
Method of measurement
Age specific gastroesophageal reflux disease questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Omeprazole syrup, 1.5 mg\kg\day, oral, twice a day, 4 weeks