UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017655
Receipt number R000020380
Scientific Title Randomized, placebo-controlled trial of Gorei-san enteroclysis in pediatric infectious gastroenteritis
Date of disclosure of the study information 2015/05/23
Last modified on 2015/12/12 10:19:46

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Basic information

Public title

Randomized, placebo-controlled trial of Gorei-san enteroclysis in pediatric infectious gastroenteritis

Acronym

Randomized trial of Gorei-san enteroclysis

Scientific Title

Randomized, placebo-controlled trial of Gorei-san enteroclysis in pediatric infectious gastroenteritis

Scientific Title:Acronym

Randomized trial of Gorei-san enteroclysis

Region

Japan


Condition

Condition

Infectious gastroenteritis

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of Gorei-san enteroclysis against infectious gastroenteritis in children.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

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

Key secondary outcomes

Reduction in severity by the Modified Vesikari Score


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Gorei-san enteroclysis

Interventions/Control_2

Placebo (10% glucose solution) enteroclysis

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

6 months-old <=

Age-upper limit

60 months-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients with vomiting or nausea
2) Patients with dehydration (CDS score: >1)
3) Patients with infectious gastroenteritis
4) Patients who can give written informed consent by own or their family
5) Patients who need infusion
6) Outpatients

Key exclusion criteria

1) Patients with vomiting symptoms associated with other diseases such as congenital disease, urinary tract infection, and acute appendicitis
2) Patients who took Gorei-san
3) Patients who are disqualified by the doctor

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitomi Hino

Organization

Shikoku Central Hospital

Division name

Division of Pediatrics

Zip code


Address

2233 Kawanoe-cho, Shikokuchuo, Ehime

TEL

089-960-5320

Email

hitomihi@m.ehime-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kentaro Ushijima

Organization

Jichi Mecical University

Division name

Division of Clinical Pharmacology, Department of Pharmacology

Zip code


Address

3311-1 Yakushiji, Shimotsuke, Tochigi

TEL

0285-58-7388

Homepage URL


Email

ushijima-kentarou@umin.ac.jp


Sponsor or person

Institute

Division of Pediatrics, Shikoku Central Hospital

Institute

Department

Personal name



Funding Source

Organization

# Shikoku Central Hospital
# Jichi Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

四国中央病院(愛媛県)、松山市民病院(愛媛県)、住友別子病院(愛媛県)、市立宇和島病院(愛媛県)、県立中央病院(愛媛県)、八幡浜病院(愛媛県)、県立新居浜病院(愛媛県)、自治医科大学(栃木県)


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 23 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2015 Year 02 Month 03 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 05 Month 22 Day

Last modified on

2015 Year 12 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020380


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name