Condition category
Infections and Infestations
Date applied
05/04/2009
Date assigned
20/04/2009
Last edited
20/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Selim Ahmed

ORCID ID

Contact details

Assistant Professor of Paediatrics
The Institute of Child and Mother Health (ICMH)
Matuail
Dhaka
1362
Bangladesh
+880 (0)2 754 2814
drselim@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of Chinese herbal medicine Goreisan (Wulingsan) on vomiting with acute watery diarrhoea in children: a randomised, double-blind, placebo-controlled clinical trial

Acronym

Study hypothesis

Goreisan is effective in reducing the frequency of acute diarrhoea and associated vomiting in children.

Ethics approval

Ethical Review Board of Institute of Child and Mother Health (ERB-ICMH) approved on the 1st April 2008

Study design

Prospective randomised, double-blind, placebo-controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute gastroenteritis with vomiting and diarrhoea

Intervention

Subjects will be stratified by sex and randomised to Goreisan (Wulingsan) powder or placebo orally in a dose of 0.25 g/kg/day (maximum of 6.0 g/day) twice a day for 3 days.

Contact details for joint Principal Investigator:
Dr Ryuichi Uchida
Thailand-Japan Research Collaboration Center on Emerging and Re-emerging Infections (RCC-ERI)
6th Fl., Building 10
Department of Medical Sciences
Ministry of Public Health
Tiwanon Road
Muang, Nonthaburi 11000
Thailand
Tel: +66 (0)2 965 9748
Fax: +66 (0)2 965 9749
E-mail: ryuryu1_u@yahoo.co.jp

Intervention type

Drug

Phase

Phase IV

Drug names

Goreisan (Wulingsan)

Primary outcome measures

1. Time to stopping of vomiting and diarrhoea after giving medicine or placebo during 72 hours of observation
2. Frequency of vomiting and diarrhoea after giving medicine or placebo during 72 hours of observation

Secondary outcome measures

1. Recovery from dehydration measured by WHO classification of dehydration in children with diarrhoea
2. Amount of oral rehydration sachets (ORS) and intravenous fluid used after giving medicine or placebo during 72 hours of observation

Overall trial start date

14/05/2008

Overall trial end date

14/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged six months up to five completed years, either sex
2. Within 3 days onset of vomiting and watery diarrhoea before enrolment
3. Cases of diarrhoea fulfilling World Health Organization (WHO) criteria (loose motion 3 times and over within 24 hours)
4. Patients with diarrhoea who are still vomiting or have at least one episode of spontaneous vomiting within 3 hours before enrolment

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Severe dehydration (WHO 2003) needing immediate intravenous fluid
2. Bloody diarrhoea
3. Anti-emetics used during this illness
4. Patients with diarrhoea and severe malnutrition
5. Any signs suggesting bacterial infections that need immediate antibiotic therapy
6. Any signs suggesting meningitis
7. Any signs suggesting ileus and/or intussusception
8. Any signs of serious systemic illness
9. Underlying congenital gastrointestinal disease
10. Other severe underlying diseases (i.e., cancer, acquired immune deficiency syndrome [AIDS], other immuno-compromised patients)
11. Past history of hospitalisation due to severe anaphylaxis to any kinds of foods or liquids

Recruitment start date

14/05/2008

Recruitment end date

14/05/2009

Locations

Countries of recruitment

Bangladesh

Trial participating centre

Assistant Professor of Paediatrics
Dhaka
1362
Bangladesh

Sponsor information

Organisation

The Institute of Child and Mother Health (ICMH) (Bangladesh)

Sponsor details

Matuail
Dhaka
1362
Bangladesh
+880 (0)2 754 2672-3/2820-3
info@icmh.org.bd

Sponsor type

Government

Website

http://www.icmh.org.bd/

Funders

Funder type

Industry

Funder name

Kotaro Pharmaceutical Co., Ltd (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes