Evaluation the effect of abdominal massage with Mastic gum oil on the reflux disease in childre

Phase 3

Recruiting

Conditions: Gastroesophageal reflux.
Gastro-esophageal reflux disease

Registration Number: IRCT20180406039204N1

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Children more than two months and less than 1 years old in aliasghar hospital
Diagnosis of GERD on the basis of GSQ-I questionnaire and pediatric gastroenterologist
Absence of serious gastrointestinal diseases such as esophagitis, achalasia, gastrointestinal ulcers, IBD (Inflamatory Bowel disease),….

Exclusion Criteria

History of allergy or skin allergy to the drug or herbal compounds
Allergy to cow's milk protein
Infants with a history of gastrointestinal surgery and neurological disease, liver, kidney, or history of severe cardio-pulmonary disease, as well as history of peptic ulcer
Guardian to cooperate in filling the forms (cognitive or language disorder).

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of css index. Timepoint: At the beginning of the study, 14 days after the intervention and 7? 28 days after discontinuation of treatment. Method of measurement: GSQ-I questionnaire.;Severity and frequency of vomiting. Timepoint: At the beginning of the study, 14 days after the intervention and 7? 28 days after discontinuation of treatment. Method of measurement: GSQ-I questionnaire.;Severity and frequency of crying and restlessness while breastfeeding. Timepoint: At the beginning of the study, 14 days after the intervention and 7? 28 days after discontinuation of treatment. Method of measurement: GSQ-I questionnaire.

Secondary Outcome Measures

Name	Time	Method
Side efect. Timepoint: Any time during the study. Method of measurement: Report by the child's supervisor.;Time Control Signs. Timepoint: Any time during the study. Method of measurement: Report by the child's supervisor.;Recurrence of symptoms. Timepoint: 7 and 28 days after discontinuation of treatment. Method of measurement: Report by the child's supervisor.