To compare the effectiveness of racecadotril versus placebo in the management of acute gastroenteritis among children with some dehydration
Design
Open labeled, randomized controlled trial
Settings and conduct
Department of pediatrics, Rai Teaching Hospital, Sargodha, Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Children of both genders, aged between 1 to 18 years, presenting with acute gastroenteritis with some dehydration.
Exclusion Criteria: Children with malnutrition, osmotic diarrhea, chronic diarrhea, or bloody diarrhea. Immunocompromised children, and children having severe dehydration
Intervention groups
Children in Racecadotril group were given oral rececadotril in addition to the standard WHO treatment for acute gastroenteritis. Children in Placebo group were given only the standard WHO treatment along with 5 ml of distilled water in the form of a placebo for acute gastroenteritis. Both groups were given designated treatments for a duaration of 3 days.
Main outcome variables
Reduction in number of stools
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221231056999N4
Registration date:2024-05-16, 1403/02/27
Registration timing:prospective
Last update:2024-05-16, 1403/02/27
Update count:0
Registration date
2024-05-16, 1403/02/27
Registrant information
Name
M Aamir
Name of organization / entity
RESnTEC, Institute of Research
Country
Pakistan
Phone
+92 321 6801143
Email address
aamir@resntec.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-01, 1403/03/12
Expected recruitment end date
2024-09-01, 1403/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Racecadotril in the Management of Acute Gastroenteritis in Children
Public title
Efficacy of Racecadotril in the Management of Acute Gastroenteritis in Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children of both genders
Aged between 1 to 18 years
Presenting with acute gastroenteritis and some dehydration
Exclusion criteria:
Children with malnutrition
Osmotic diarrhea
Chronic diarrhea
Bloody diarrhea
Immunocompromised children
Severe dehydration
Age
From 1 year old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using envelop system. The envelopes were shuffled to ensure randomness. The envelopes were opened one by one, and each participant was allocated to either the Racecadotril group or the Placebo group. This process ensured that each participant had an equal chance of being assigned to either group, reducing the potential for bias in the assignment process. Children in Racecadotril group were given oral rececadotril in addition to the standard WHO treatment for acute gastroenteritis. Children in Placebo group were given only the standard WHO treatment along with 5 ml of distilled water in the form of a placebo for acute gastroenteritis.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Ethical and Research Committee, Rai Medical College & Teaching Hospital, Sargodha
Street address
6 Km Islamabad Road Sargodha
City
Sargodha
Postal code
4100
Approval date
2022-08-15, 1401/05/24
Ethics committee reference number
ERC/2022/093
Health conditions studied
1
Description of health condition studied
Acute Gastroenteritis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduction in number of stools
Timepoint
3 days
Method of measurement
Parents or guardians of the studied children will be telephonically contacted and asked about the number of stools per day after 3 days of treatment.
Secondary outcomes
empty
Intervention groups
1
Description
racecadotril group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The department of pediatrics, Rai Teaching Hospital
Full name of responsible person
Dr. Sadaf Liaqat
Street address
6 Km Islamabad Road Sargodha
City
Sargodha
Postal code
40100
Phone
+92 306 6006806
Email
sadafliaqat09@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rai Medical College, Sargodha, Pakistan
Full name of responsible person
Dr. Sadaf Liaqat
Street address
6 Km Islamabad Road Sargodha.
City
Sargodha
Postal code
41100
Phone
+92 306 6006806
Email
sadafliaqat09@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rai Medical College, Sargodha, Pakistan
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Pediatric Medicine, Rai Medical College, Sargodha
Full name of responsible person
Dr. Sadaf Liaqat
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
6 Km Islamabad Road Sargodha.
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 306 6006806
Email
sadafliaqat09@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Pediatric Medicine, Rai Medical College, Sargodha
Full name of responsible person
Dr. Sadaf Liaqat
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
6 Km Islamabad Road Sargodha.
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 306 6006806
Email
sadafliaqat09@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Department of Pediatric Medicine, Rai Medical College, Sargodha
Full name of responsible person
Dr. Sadaf Liaqat
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
6 Km Islamabad Road Sargodha.
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 306 6006806
Email
sadafliaqat09@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Not applicable
When the data will become available and for how long
6 months after publication
To whom data/document is available
All
Under which criteria data/document could be used
Contact corresponding author
From where data/document is obtainable
Contact corresponding author
What processes are involved for a request to access data/document