Effect of Chinese herbal medicine Goreisan (Wulingsan) on vomiting with acute watery diarrhoea in children

ISRCTN	ISRCTN34440093
DOI	https://doi.org/10.1186/ISRCTN34440093
Protocol serial number	N/A
Sponsor	The Institute of Child and Mother Health (ICMH) (Bangladesh)
Funder	Kotaro Pharmaceutical Co., Ltd (Japan)

Submission date: 05/04/2009
Registration date: 20/04/2009
Last edited: 20/04/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Selim Ahmed
Scientific

Assistant Professor of Paediatrics
The Institute of Child and Mother Health (ICMH)
Matuail
Dhaka
1362
Bangladesh

Phone	+880 (0)2 754 2814
Email	drselim@gmail.com

Study information

Primary study design	Interventional
Study design	Prospective randomised, double-blind, placebo-controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	Goreisan is effective in reducing the frequency of acute diarrhoea and associated vomiting in children.
Ethics approval(s)	Ethical Review Board of Institute of Child and Mother Health (ERB-ICMH) approved on the 1st April 2008
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Goreisan (Wulingsan)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	14/05/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	5 Years
Sex	All
Target sample size at registration	400
Key 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
Key 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
Date of first enrolment	14/05/2008
Date of final enrolment	14/05/2009

Locations

Countries of recruitment

Bangladesh

Study participating centre

Assistant Professor of Paediatrics

Dhaka
1362
Bangladesh

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes