This trial is a phase 3, single-center, randomized, double blinded, placebo controlled clinical trial to evaluate the effect of “myrtle fruit syrup" on Gastro-Esophageal Reflux Disease (GERD) in children.
The sample size is 50 containing 25 in every group. 1 to 7 years old children attending gastroenterology clinic of Bahrami’s children hospital who are diagnosed as GERD patients according to GSQ-YC (GERD Symptom Questionnaire-Young Child) and pediatric gastroenterologist are recruited in the study, are allocated to intervention group (omeprazole and “myrtle fruit syrup") or control group (omeprazole and placebo syrup). One week after starting the treatment, via telephone contact, parents are asked about the time when the maximum effect of treatment has been observed as well as satisfaction rate with syrup form and capsule form. Treatment period is 2 months. GERD Symptom Questionnaire for Young Child (GSQ-YC) will be filled out after 2 and 3 months from starting the treatment. Finally, comparison between questionnaires data will be done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061828521N1
Registration date:2016-09-04, 1395/06/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Maryam al-sadat Paknejad
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 457 3486
Email address
m-paknejad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-08-05, 1395/05/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double blind randomized clinical trial in treatment of gastroesophageal reflux disease in children with Myrtus Communis L. (Myrtle) fruit.
Public title
The effect of myrtle fruit syrup on children reflux disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. 1 to 7 years old children attended to Bahrami’s children hospital gastro-enterology clinic;
2. Diagnosis of GERD on the basis of GSQ-YC questionnaire and pediatric gastroenterologist;
3. Absence of serious gastrointestinal diseases such as esophagitis, achalasia, gastrointestinal ulcers, IBD (Inflamatory Bowel disease),….;
4. Absence of GERD complications such as: esophagitis and ulcers;
5. Absence of every serious condition such as severe asthma;
6. Absence of gastrointestinal anomalies;
7. Absence of cognitive or mental disorders;
8. Absence of history of PPIs (Proton Pomp Inhibitors) or H2 Blockers consumption in 1 week before;
9. Absence of severe constipation;
Exclusion criteria:
1. Patient’s lack of tendency to continue the trial;
2. Significant conditions which can be considered as drug side effects;
3. Exacerbation of GERD symptoms throughout the trial;
4. Allergy history to myrtle;
5. Significant history of allergy to herbal compounds or food allergy;
Age
From 1 year old to 7 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina St, 16 Azar St, Tehran, Iran.
City
Tehran
Postal code
Approval date
2016-06-18, 1395/03/29
Ethics committee reference number
IR.TUMS.REC.1395.2699
Health conditions studied
1
Description of health condition studied
gasteroesophageal reflux disease
ICD-10 code
K21
ICD-10 code description
Gastro-oesophageal reflux disease
Primary outcomes
1
Description
Vomiting / Regurgitation
Timepoint
0th, 2nd, 3rd month after treatment start
Method of measurement
GSQ-YC questionnaire
2
Description
Choking when eating
Timepoint
0th, 2nd, 3rd month after treatment start
Method of measurement
GSQ-YC questionnaire
3
Description
Abdominal pain
Timepoint
0th, 2nd, 3rd month after treatment start
Method of measurement
GSQ-YC questionnaire
4
Description
Burping / belching
Timepoint
0th, 2nd, 3rd month after treatment start
Method of measurement
GSQ-YC questionnaire
5
Description
Difficulty swallowing
Timepoint
0th, 2nd, 3rd month after treatment start
Method of measurement
GSQ-YC questionnaire
6
Description
Refusal to eat
Timepoint
0th, 2nd, 3rd month after treatment start
Method of measurement
GSQ-YC questionnaire
Secondary outcomes
1
Description
side effect
Timepoint
any time throughout the survey
Method of measurement
babysitter report
2
Description
anti-acid use frequency
Timepoint
0th, 2nd, 3rd month after treatment start
Method of measurement
babysitter report
3
Description
drug's form satisfaction
Timepoint
7th day after treatment start
Method of measurement
babysitter report
4
Description
maximum efficacy
Timepoint
7th day after treatment start
Method of measurement
babysitter report
Intervention groups
1
Description
Intervention group is received omeprazole capsules and Myrtle fruit syrup. Omeprazole (Abidi®) will be prescribed 1 mg/kg/day in 2 divided Dose, 15 min before child feeding while Myrtle fruit syrup will be prescribed 0.21 mg/kg/day in 3 divided Dose, after child feeding. Treatment course will be 2 months.
Category
Treatment - Drugs
2
Description
Control group is received omeprazole capsules and placebo syrup. Omeprazole (Abidi®) will be prescribed 1 mg/kg/day in 2 divided Dose, 15 min before child feeding while placebo syrup will be prescribed 0.21 mg/kg/day in 3 divided Dose, after child feeding. Treatment course will be 2 months.