Unique ID issued by UMIN | UMIN000017655 |
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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 |
Randomized, placebo-controlled trial of Gorei-san enteroclysis in pediatric infectious gastroenteritis
Randomized trial of Gorei-san enteroclysis
Randomized, placebo-controlled trial of Gorei-san enteroclysis in pediatric infectious gastroenteritis
Randomized trial of Gorei-san enteroclysis
Japan |
Infectious gastroenteritis
Pediatrics |
Others
NO
To evaluate the efficacy and safety of Gorei-san enteroclysis against infectious gastroenteritis in children.
Safety,Efficacy
Time until liveliness (scored by modified performans status) becomes 0
Reduction in severity by the Modified Vesikari Score
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
Central registration
2
Treatment
Medicine |
Gorei-san enteroclysis
Placebo (10% glucose solution) enteroclysis
6 | months-old | <= |
60 | months-old | >= |
Male and Female
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
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
50
1st name | |
Middle name | |
Last name | Hitomi Hino |
Shikoku Central Hospital
Division of Pediatrics
2233 Kawanoe-cho, Shikokuchuo, Ehime
089-960-5320
hitomihi@m.ehime-u.ac.jp
1st name | |
Middle name | |
Last name | Kentaro Ushijima |
Jichi Mecical University
Division of Clinical Pharmacology, Department of Pharmacology
3311-1 Yakushiji, Shimotsuke, Tochigi
0285-58-7388
ushijima-kentarou@umin.ac.jp
Division of Pediatrics, Shikoku Central Hospital
# Shikoku Central Hospital
# Jichi Medical University
Self funding
NO
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)
2015 | Year | 05 | Month | 23 | Day |
Unpublished
Enrolling by invitation
2015 | Year | 02 | Month | 03 | Day |
2015 | Year | 06 | Month | 01 | Day |
2015 | Year | 05 | Month | 22 | Day |
2015 | Year | 12 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020380
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