NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061180097

Registered date:22/03/2019

Randomized trial of Gorei-san enteroclysis

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedInfectious gastroenteritis
Date of first enrollment29/10/2015
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Enteroclysis of Gorei-san or 10% glucose solution Active treatment group: To dissolve 2.5 g of Gorei-san with 20 ml of distilled water *under 10 kg : Enteroclysis of 10 ml of mixture *over 10 kg : Enteroclysis of 20 ml of mixture Placebo group : Enteroclysis of 10 or 20 ml of 10 % glucose solution

Outcome(s)

Primary OutcomeTime until liveliness (scored by modified perfomance status ) becomes 0
Secondary OutcomeReduction in severity by the Modified Vesikari Score

Key inclusion & exclusion criteria

Age minimum>= 6month old
Age maximum<= 5age old
GenderBoth
Include criteriaPatients with vomiting or nausea Patients with dehydration (CDS score >1) Patients with infectious gastroenteritis Patients who can give written informed consent by own or their family Patients who need infusion Outpatients (Admission after enrollment is permitted)
Exclude criteriaPatients with vomiting symptoms associated with other diseases such as congenital disease, urinary tract infection, and acute appendicitis Patients who took Gorei-san Hypoglycemia (plasma glucose <45mg/dl) Patients who are disqualified by the doctor Patients who received instillation for the present symptoms within 7 days before enrollment.

Related Information

Contact

Public contact
Name Hitomi Hino
Address 3-1-1, Hongo,Niihama,Ehime,Japan Ehime Japan 792-0042
Telephone +81-897-43-6161
E-mail hitomihi1234@gmail.com
Affiliation Ehime Prefectural Niihama Hospital
Scientific contact
Name Hiroki Hirai
Address Shitsukawa,Toon,Ehime,Japan Ehime Japan 791-0295
Telephone +81-89-964-5111
E-mail hiraih113@gmail.com
Affiliation Ehime University Graduate School of Medicine