Evaluation of N-acetylcysteine efficacy compared to placebo in the treatment of diarrhea caused by rotavirus in children: a randomized, double-blind clinical trial.
Determining the effectiveness of N-acetylcysteine in the treatment of diarrhea caused by rotavirus in children
Design
Control-controlled clinical trial with parallel, double-blind, randomized, phase 3 groups on 64 patients used the Excel software rand function for randomization.
Settings and conduct
This project was carried out at Shahid Sadoughi Hospital in Yazd. The patients in the drug group were given 60 mg/kg/day of N-acetylcysteine in three divided doses and placebo was given to the control group. In both groups, patients will receive supportive treatment such as ORS.
Participants/Inclusion and exclusion criteria
Children aged 6 months to 5 years with diarrhea caused by rotavirus, who do not have a specific underlying disease, do not have allergy to N-acetylcysteine, and do not take ibuprofen.
Intervention groups
In order to evaluate the effectiveness of N-acetylcysteine in the treatment of diarrhea caused by rotavirus, a group of 32 people is given N-acetylcysteine and a group of 32 people is given a placebo.
Main outcome variables
The number of days of the patient's diarrhea, the number of stools per day
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N13
Registration date:2023-10-14, 1402/07/22
Registration timing:retrospective
Last update:2023-10-14, 1402/07/22
Update count:0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of N-acetylcysteine efficacy compared to placebo in the treatment of diarrhea caused by rotavirus in children: a randomized, double-blind clinical trial.
Public title
N-acetylcysteine in the treatment of diarrhea caused by rotavirus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Rotavirus infection has been confirmed in patient.
The age range of the patient is between 6 months and 5 years
Absence of genetic or chronic diseases in patients
Insensitivity to N-acetylcysteine
Do not receive ibuprofen
Exclusion criteria:
Patients who refer after 48 hours from the onset of diarrhea.
Patients who receive ibuprofen.
Hypersensitivity to N-acetylcysteine
Age
From 6 months old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 64 patients were randomly divided into two treatment groups (A and B). In order to randomize, the block random allocation method was used, in which 13 blocks of 5 were considered. The letters A and B. These permutations were generated with the help of Random software distribution software version 1. For this purpose, the list prepared by software No. 1 to 64 is in 13 blocks of five in general to implement this I want the software output to the first eligible person number 1 and I want to select the last person number 64.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, the physician, and the assessor of clinical symptoms will be all blinded to the intervention’s assignments during performing the study. In this way, the first executor of the sequence plan determines the allocation of individuals according to the order in which patients enter the study and puts N-acetyl cysteine and placebo syrups (They are the same in terms of packaging) in the same shape boxes for patient consumption. And identifies them with codes A or B. The student then delivers the appropriate medications to the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine- Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2017-02-15, 1395/11/27
Ethics committee reference number
IR.SSU.MEDICINE.REC.1395.338
Health conditions studied
1
Description of health condition studied
Diarrhea caused by rotavirus
ICD-10 code
A08.0
ICD-10 code description
Rotaviral enteritis
Primary outcomes
1
Description
Investigation of duration and frequency of diarrhea
Timepoint
Days zero to seven
Method of measurement
Frequency of diarrhea per day and duration of diarrhea
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients aged 6 months to 5 years with diarrhea caused by rotavirus receive 60 mg/kg N-acetylcysteine syrup daily (prepared at Yazd Faculty of Pharmacy) in 3 divided doses orally until the end of the diarrhea period.
Category
Treatment - Drugs
2
Description
Control group: Patients aged 6 months to 5 years with diarrhea caused by rotavirus receive daily placebo syrup (prepared in Yazd Pharmacy Faculty) in 3 divided doses orally until the end of the diarrhea period.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid sadoughi hospital
Full name of responsible person
Majid Aflatunian
Street address
Ibn Sina Street, Shahid Ghandi Boulevard, Safaieh, Yazd.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3822 4000
Email
sadoghi-hospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
امین صالحی ابرقوئی
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3146 2150
Email
abargouei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After nonrecognition, all data can be share
When the data will become available and for how long
6 months after publication
To whom data/document is available
All of researchers
Under which criteria data/document could be used
Nothing
From where data/document is obtainable
Behrooz Heydari email: b.heydari@ssu.ac.ir
What processes are involved for a request to access data/document
Request your information by email. The data will be sent after a week.