Effects of probiotic on resistant chronic urticaria severity - quality of life
Design
All of participants divided into two groups based on simple randomization. Each group has 20. This is phase 3
Settings and conduct
This is a double blind study in tooba clinic and boali hospital in sari
Participants/Inclusion and exclusion criteria
Inclusion criteria; resistant chronic urticaria, 5 to 30 years old
Exclusion criteria: use probiotic, second arry urticaria, other disorders
Intervention groups
20 patients with chronic urticaria take antihistamines and probiotic
Main outcome variables
Resolution chronic urticaria severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110531006660N9
Registration date:2020-07-24, 1399/05/03
Registration timing:retrospective
Last update:2020-07-24, 1399/05/03
Update count:0
Registration date
2020-07-24, 1399/05/03
Registrant information
Name
Javad Ghafari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 0054
Email address
ghafari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
2019-06-22, 1398/04/01
Actual recruitment end date
2019-06-22, 1398/04/01
Trial completion date
2020-02-20, 1398/12/01
Scientific title
Effect probiotic on resistant chronic urticaria
Public title
Probitic in chronic urticaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Resistant chronic urticaria
5 to 30 years old
Exclusion criteria:
Consumption of probiotic in the last 2 months
Second urticaria
other Known disorders
consumption of antibiotic in the last 2 months
Age
From 5 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, each patient selected based on table of random divided to each group . such as 1,4,7 and ...in one group; 2,3,5,6,8,9 and ...in another group based on randomization number.
Blinding (investigator's opinion)
Double blinded
Blinding description
All of participants, physician, data collector, data analyzer. after selection of patients, take drug or placebo from pharmacy. only pharmacologist known about treatment. finally data send to supervisor without name and without kind of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical sciences
Street address
Pasadaran Blvd-Boali hospital
City
Sari
Province
Mazandaran
Postal code
4815838477
Approval date
2018-08-20, 1397/05/29
Ethics committee reference number
IR.MAZUMS.REC.1398.163
Health conditions studied
1
Description of health condition studied
Chronic urticaria
ICD-10 code
L50.1
ICD-10 code description
Idiopathic urticaria
Primary outcomes
1
Description
Resolution chronic urticaria severity
Timepoint
Before, 4 and 8 weeks after treatment
Method of measurement
Questionnaire- UAS7 and QOLI
Secondary outcomes
1
Description
Resolution chronic urticaria quality of life
Timepoint
Before, 4 and 8 weeks after treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: 20 patient with CU resistant to treatment treated with cetirizine 10mg BID/day and probiotic 1000 mg /day for 8 weeks. all of them completing questionnaire before, 4 and 8 weeks after treatment.
Category
Treatment - Drugs
2
Description
Control group: 20 patient with CU resistant to treatment treated with cetirizine 10mg BID/day and placebo one cap sol /day for 8 weeks. all of them completing questionnaire of severity and quality of life before, 4 and 8 weeks after treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tooba clinic and boali hospital
Full name of responsible person
Javad Ghaffari
Street address
Pasdaran blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3326 0054
Email
Javadneg@Yahoo
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Reza Alizadeh Navaei
Street address
Pasdaran blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3326 0053
Email
Reza.nava@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Javad Ghaffari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pasdaran blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3326 0054
Email
Javadneg@Yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Javad Ghaffari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pasdaran blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3326 0054
Email
Javadneg@Yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Javad Ghaffari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pasdaran blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3326 0054
Email
Javadneg@Yahoo.com
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
Yes
When the data will become available and for how long
After end of research
To whom data/document is available
All
Under which criteria data/document could be used
No
From where data/document is obtainable
Email
What processes are involved for a request to access data/document