Effect of Chinese herbal medicine Goreisan (Wulingsan) on vomiting with acute watery diarrhoea in children
| ISRCTN | ISRCTN34440093 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34440093 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Assistant Professor of Paediatrics
The Institute of Child and Mother Health (ICMH)
Matuail
Dhaka
1362
Bangladesh
| Phone | +880 (0)2 754 2814 |
|---|---|
| drselim@gmail.com |
Study information
| Study design | Prospective randomised, double-blind, placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Goreisan (Wulingsan) |
| Primary outcome measure | 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 study start date | 14/05/2008 |
| Completion date | 14/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 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
1362
Bangladesh
Sponsor information
The Institute of Child and Mother Health (ICMH) (Bangladesh)
Government
Government
Matuail
Dhaka
1362
Bangladesh
| Phone | +880 (0)2 754 2672-3/2820-3 |
|---|---|
| info@icmh.org.bd | |
| Website | http://www.icmh.org.bd/ |
"ROR" |
https://ror.org/05dm6kv37 |
Funders
Funder type
Industry
Kotaro Pharmaceutical Co., Ltd (Japan)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
