Objectives: To assess the effect of apple juice and carrot juice on the duration of diarrhea in children with acute watery diarrhea. Design: A randomized clinical trial. Setting and conduct: The eligible patients with complaints of diarrhea referred to Shahid Beheshti Hospital will be enrolled into the trial. Inclusion criteria: Age 1-5 years, Acute watery diarrhea. Exclusion criteria: High fever (T>38.5°C), Severe dehydration, Bloody diarrhea, Severe malnutrition, Using of antibiotics or anti-diarrheal drugs, Patients with more than one complain, Immune deficiency. Intervention group 1: Oral administration of apple juice 15 milliliters per kilogram of body weight every 12 hours for 5 days plus ORS. Intervention group 2: Oral administration of carrot juice 15 milliliters per kilogram of body weight every 12 hours for 5 days plus ORS. Control group: Administration of ORS without fruit juice. Primary outcome: Duration of diarrhea by asking from patient or mother, frequency of diarrhea by asking from patient or mother.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101711145N17
Registration date:2017-01-05, 1395/10/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-05, 1395/10/16
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research and Technology, Kashan University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of apple juice and carrot juice on duration of acute watery diarrhea in children
Public title
Evaluation of the effect of apple juice and carrot juice on acute watery diarrhea in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 1-5 years; Acute watery diarrhea Exclusion criteria: High fever (T>38.5°C); Severe dehydration; Bloody diarrhea; Severe malnutrition; Using of antibiotics or anti-diarrheal drugs; Patients with more than one complain; Immune deficiency
Age
From 1 year old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2016-12-07, 1395/09/17
Ethics committee reference number
IR.KAUMS.REC.1395.95
Health conditions studied
1
Description of health condition studied
Acute watery diarrhea
ICD-10 code
A09.9
ICD-10 code description
Gastroenteritis and colitis of unspecified origin
Primary outcomes
1
Description
Duration of diarrhea
Timepoint
Daily
Method of measurement
Asking from patient or mother
2
Description
Frequency of diarrhea
Timepoint
Daily
Method of measurement
Asking from patient or mother
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Oral administration of apple juice 15 milliliters per kilogram of body weight every 12 hours for 5 days plus ORS.
Category
Treatment - Drugs
2
Description
Intervention group 2: Oral administration of carrot juice 15 milliliters per kilogram of body weight every 12 hours for 5 days plus ORS.
Category
Treatment - Drugs
3
Description
Control group: Administration of ORS without fruit juice.