The effect of date kernel suspension on reduction of severity and duration of diarrhea in gastroenteritis patients
Design
This study is a double-blind randomized controlled clinical trial on patients with gastroenteritis referred to Abuzar hospitals in Ahvaz. . Eligible patients will then be randomly divided into two experimental and control groups. The age range of children between 2 years and 8 years was selected. At baseline, there was no difference between the two groups in terms of sex, age, diet, weight, duration of diarrhea, and degree of hydration. For the first group of palm kernel suspensions, 3% in the amount of 3 mg per kilogram of body weight is administered orally every 8 hours for 7 days.
for the second group, placebo is prescribed every 8 hours.
Settings and conduct
abuzar children hospital .
Intervention Patients were randomly divided into intervention and control groups (based on random number table). For the first group of palm kernel suspensions, 3% in the amount of 3 mg per kilogram of body weight is administered orally every 8 hours for 7 days.
And for the second group, placebo is prescribed once every 8 hours.
Participants/Inclusion and exclusion criteria
Entry requirements:
Patients with gastroenteritis, age between 24 and 96 months, no drug treatment before entering the study and completing the consent form
Conditions of non-entry:
1-Severe dehydration
2-There are abnormal findings in stool tests such as wbc blood equal to or above 5 or parasite
3-There is a problem with surgery, such as acute abdominal surgery
4-Having another illness or taking another medicine while studying
5-Frequent vomiting and intolerance to the drug
Intervention groups
Patients were randomly divided into two intervention and control groups, randomly assigned to either the intervention or the placebo control group.
Main outcome variables
Severity and duration of diarrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200202046341N1
Registration date:2020-06-22, 1399/04/02
Registration timing:registered_while_recruiting
Last update:2020-06-22, 1399/04/02
Update count:0
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Neda Mohtasham
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3551 2845
Email address
mohtasham-n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-26, 1399/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of date kernel suspension on reduction of severity and duration of diarrhea in Patients with gastroenteritis
Public title
The effect of date kernel suspension on reduction of severity and duration of diarrhea in Patients with gastroenteritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All children aged 24 months to 96 months with acute gastroentrit
No drug treatment before enrollment
Completion of parental consent form
Symptoms less than or equal to 24 hours
Exclusion criteria:
Severe dehydration
Abnormal findings in stool exam such as wbc equal or above 5 in stool or parasite in stool
There is a surgical problem such as acute abdominal surgery
Having another illness or taking another drug while studying
Failure to adhere to treatment protocol or abandon treatment before complete recovery
Frequent vomiting and intolerance to medication
Patient Withdrawal from Study Participation
Age
From 24 months old to 96 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two intervention and control groups according to the random number table. The intervention group received the suspension and the control group received placebo .
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both participants and their parents, as well as researchers and evaluators, are unaware of the consequences of determining which group they are in.drug and placebo are given to patients based on a pre-determined random numbering.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
AhAhvaz Jundishapur University of Medical Science
Street address
Golestan
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-03-14, 1398/12/24
Ethics committee reference number
IR.AJUMS.REC.1398.960
Health conditions studied
1
Description of health condition studied
Acute gastroenteritis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Assess the severity and duration of diarrhea
Timepoint
The efficacy of the drug in the first, second and seventh days
Method of measurement
Reduce the number of diarrhea at the end of the first, third and seventh days
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:For the first group, 3% palm kernel suspension is given at a dose of 3 mg per kg body weight orally every 8 hours for 7 days. for the control group, placebo is prescribed three times a day (once every 8 hours).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Abuzar Children's Hospital
Full name of responsible person
نادر شفیعی
Street address
زیتون
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3444 9003
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
محمد بدوی
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Fax
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
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
Ahvaz University of Medical Sciences
Full name of responsible person
Amanollah Zarei Ahmady
Position
دانشیار
Latest degree
Ph.D.
Other areas of specialty/work
Chemistry
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8382
Email
amanzarei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Mohtasham
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Zeytoon
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
0098613311
Fax
+98 61 3373 8383
Email
amanzarei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nader Shafiee
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Zeytoon
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
amanzarei@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available