Randomized trial of Gorei-san enteroclysis

JRCT ID: jRCTs061180097

Registered date:22/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Infectious gastroenteritis
• Date of first enrollment: 29/10/2015
• Target sample size: 50
• Study type: Interventional

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 Outcome

Time until liveliness (scored by modified perfomance status )
becomes 0

• Secondary Outcome: Reduction in severity by the Modified Vesikari Score

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: <= 5age old
• Gender: Both

Include criteria

Patients 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 criteria

Patients 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

• Primary Sponsor: Niino Ryoji
• Secondary ID(s): UMIN000017655