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The effect of Quince syrup in pediatric gastroesophageal reflux aged 12 to 48 months

Comparison of the effect of ranitidine syrup with Quince syrup in pediatric gastroesophageal reflux aged 12 to 48 months

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170501033750N2
Enrollment
80
Registered
2018-04-20
Start date
2017-06-10
Completion date
Unknown
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-oesophageal reflux. Gastro-esophageal reflux disease

Interventions

Intervention 1: The intervention group are given quince syrup twice daily with ranitidine syrup for 4 weeks. Intervention 2: The placebo control group are given sugar syrup twice daily with ranitidine

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 4 Years

Inclusion criteria

Inclusion criteria: Patients in the age group of 12 to 48 months. People with at least 2 times a week with common symptoms of reflux disease (heartburn, regurgitation, vomiting, epigastric pain and appropriate weight loss for at least a month Those who are newly diagnosed or who have been suffering from reflux, have not taken any medications for at least one month and will want to start their treatment again

Exclusion criteria

Exclusion criteria: Patients with severe reflux disease (severe onset: symptoms of severe esophagitis, vomiting, life-threatening symptoms such as apnea, pneumonia, esophageal stricture and systemic diseases) due to the need for treatments Another intervention, including surgery or other medications, is withdrawn from the project because of ethical considerations (non-deprivation of the patient and non-risk for the volunteers) Children with a disease (neurological, cardiac, pulmonary, liver and kidney) or mental retardation People who have used other herbal remedies during this period People who need to use chemical drugs during the plan due to the specific disease People with a history of allergy to herbal medicines

Design outcomes

Primary

MeasureTime frame
Severity of nausea. Timepoint: A week before treatment, the second, fourth and sixth weeks after treatment. Method of measurement: GSQ-YC standard questionnaire.;Numbers of vomiting. Timepoint: A week before treatment, the second, fourth and sixth weeks of treatment. Method of measurement: GSQ-YC standard questionnaire.;Severity of hiccups. Timepoint: The beginning of the week, the second week, the fourth, the sixth. Method of measurement: GSQ-YC standard questionnaire.;Severity of abdominal pain. Timepoint: The beginning of the week, the second week, the fourth, the sixth. Method of measurement: GSQ-YC standard questionnaire.;Freqency of abdominal pain. Timepoint: The beginning of the week, the second week, the fourth, the sixth. Method of measurement: GSQ-YC standard questionnaire.;Severity of regurgitation. Timepoint: The beginning of the week, the second week, the fourth, the sixth. Method of measurement: GSQ-YC standard questionnaire.;Frequency of hiccups. Timepoint: The beginning of the week, the second week, the fourth, the sixth. Method of measurement: GSQ-YC standard questionnaire.

Secondary

MeasureTime frame
Refuse to eat. Timepoint: The last week of treatment, the second week of the fourth and sixth treatment. Method of measurement: GSQ-YC standard questionnaire.;Inappropriate weighing. Timepoint: Before starting treatment and then finishing treatment for the sixth week. Method of measurement: Baby growth curve.;Swallowing disorder. Timepoint: Before starting treatment and during treatment until the 6th week. Method of measurement: GSQ-YC standard questionnaire.;Side effects. Timepoint: Any time during treatment. Method of measurement: Baby Nurse Report.;Repeated use of anti-acid. Timepoint: First and second months of treatment. Method of measurement: Baby Nurse Report.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Naeimi

Babol University of Medical Sciences

naeimima@yahoo.com+98 11 3219 2832

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026