Comprehensive studies of a new improved oral rehydration solution for diarrhoeal disease: physiological and molecular studies, clinical trials, and acceptability and efficacy studies in a rural south Indian community
| ISRCTN | ISRCTN72841333 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72841333 |
| Secondary identifying numbers | 063150 |
- Submission date
- 22/07/2005
- Registration date
- 22/07/2005
- Last edited
- 06/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Balakrishnan S Ramakrishnan
Scientific
Scientific
Christian Medical College
Williams Research Building
Department of Gastrointestinal Science
Ida Scudder Road
Vellore
632004
India
| Phone | +91 (0)416 2282052 |
|---|---|
| rama@cmcvellore.ac.in |
Study information
| Study design | Randomised single-blinded controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Comprehensive studies of a new improved oral rehydration solution for diarrhoeal disease: physiological and molecular studies, clinical trials, and acceptability and efficacy studies in a rural south Indian community |
| Study objectives | The hypothesis is that addition of amylase resistant starch to a low osmolarity Oral Rehydration Solution (ORS) will reduce the duration and severity of diarrhoea in a variety of diarrhoeal diseases including cholera and non-cholera diarrhoea. The studies consist of two randomised trials in adults and children respectively comparing the newly recommended low osmolar ORS to low osmolar ORS with added amylase resistant starch. The objective is to determine whether subjects in the trial arm will have reduced stool output and duration of diarrhoea. The overall trial end date was changed from 15/03/2006 to 31/01/2007. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Diarrhoea |
| Intervention | Eligible subjects will be randomised to one of two treatment arms to receive either reduced osmolarity ORS or reduced osmolarity ORS along with amylase resistant starch. All other treatment measures will be identical in the two groups. ORS will be administered according to World Health Organisation (WHO) treatment guidelines for management of acute diarrhoea. Stool consistency and weight will be determined by personnel unaware of the treatment received by the patient. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Amylase resistant starch, low osmolarity Oral Rehydration Solution (ORS) |
| Primary outcome measure | 1. Stool weight in successive 12 hour periods 2. Stool weight in the second 24 hours 3. Time to last unformed stool 4. Requirement for unscheduled intravenous fluids |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/01/2005 |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Male |
| Target number of participants | To be added |
| Key inclusion criteria | In the adult study, all adult male patients presenting to the Emergency Service with acute severe watery diarrhoea of less than three days' duration, with moderate to severe dehydration, will be enrolled after informed written consent. In a separate trial, male children aged six months to five years with diarrhoea (defined as more than three watery stools/24 hours) of three days or less, with mild or moderate dehydration, or those with severe dehydration who have received intravenous rehydration, will be enrolled after informed written consent from the parent. |
| Key exclusion criteria | In the adult trial, subjects without clinical dehydration, those with presence of blood in stool, and presence of significant systemic illness unrelated to the diarrhoea, will be excluded. In the children's trial, bloody diarrhoea, concurrent severe illness (such as pneumonia, meningitis or infections requiring antibiotics), and severe malnutrition Grade III and IV will be treated as exclusion criteria. |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- India
Study participating centre
Christian Medical College
Vellore
632004
India
632004
India
Sponsor information
Christian Medical College (India)
Hospital/treatment centre
Hospital/treatment centre
c/o George M Chandy
Ida Scudder Road
Vellore
632004
India
| Phone | +91 (0)416 2282052 |
|---|---|
| directorate@cmcvellore.ac.in | |
| Website | http://cmcvellore.ac.in |
"ROR" |
https://ror.org/00c7kvd80 |
Funders
Funder type
Charity
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/02/2008 | Yes | No |
