Comparison of the effectiveness of probiotic and antihistamine therapy with antihistamine therapy alone in reducing the number of urticaria and pruritus in chronic urticaria patients
Comparison of the effectiveness, complications, tolerance and satisfaction of probiotic and antihistamine therapy with antihistamine therapy alone in reducing the number of urticaria and pruritus in chronic urticaria patients
Design
A randomized controlled clinical trial with parallel groups
Settings and conduct
Being carried out at the dermatology department of Rasool-E-Akram Hospital.
At first they complete questionnaire 1. It includes demographic information including age, sex, occupation, weight, marital status, contact number and address, duration of hives, number of days per week, as well as previous antihistamine use history and type.
Completion of Questionnaire 2 which is the Number and Severity of Hives and Questionnaire 3 related to quality of life
Targeted trials
Grouping patients into two groups randomly
Patients should be treated for 8 weeks. First of all at the first visit then eighth week questionnaires number 2 and 3 will be completed by physicians.
Without any blinding
Participants/Inclusion and exclusion criteria
Inclusion criteria: urticaria in at least two days a week for at least 6 weeks; Age between 18 and 45 years.
Non-Inclusion criteria: Serious comorbidities; Taking any drug other than antihistamines; Having vasculitis.
Intervention groups
Intervention group: For this group of patients, treatment includes only antihistamines.Two antihistamines is given twice daily and the type of them is prescribed based on the patient's condition and tolerance.These antihistamines are selected from cetirizine, desloratadine (neotadine) and fexofenadine. In addition, two lactocare capsules are prescribed too which are containing two probiotics.
Control group: Second group will be treated only with the antihistamines listed above.
Main outcome variables
Pruritus severity; urticaria activity score over 7 days (UAS7); Number of hives; Complications; tolerance of treatment; satisfaction; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190825044613N1
Registration date:2019-12-15, 1398/09/24
Registration timing:registered_while_recruiting
Last update:2019-12-15, 1398/09/24
Update count:0
Registration date
2019-12-15, 1398/09/24
Registrant information
Name
Shokoufeh Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 6773
Email address
sharifishokoufeh67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of probiotic and antihistamine therapy with antihistamine therapy alone in reducing the number of urticaria and pruritus in chronic urticaria patients
Public title
Effect of Probiotic in reducing urticaria and pruritus in people with chronic urticaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
For at least two days of week patients must have urticaria lesions and these lesions must remain for at least 6 weeks.
Age between 18 to 45 years old
Exclusion criteria:
Serious comorbidities (such as malignancies, mental illness, hepatitis, endocrine or other acute and chronic systemic diseases)
Taking any drug other than antihistamines
Patients with vasculitis
Patients with urticaria due to autoimmune diseases
A history of severe gastrointestinal diseases such as indigestion and malabsorption
Patients taking corticosterone for any reason
A history of asthma and allergies in the patients and their first degree relatives
Patients with severe mental problems
Age
From 18 years old to 45 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two main groups after first visit. Patients with odd number in the list are included in to group 1 and patients with even number are included in group 2.
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-02-26, 1397/12/07
Ethics committee reference number
IR.IUMS.FMD.REC.1398.129
Health conditions studied
1
Description of health condition studied
Hives
ICD-10 code
L50.9
ICD-10 code description
Urticaria, unspecified
Primary outcomes
1
Description
Itching severity
Timepoint
first visit - 8 Week after treatment
Method of measurement
Questionnaire and visit
2
Description
urticaria activity score over 7 days (UAS7)
Timepoint
first visit -- 8 Week after treatment
Method of measurement
Questionnaire and visit
3
Description
Number of hives
Timepoint
first visit - 8 Week after treatment
Method of measurement
Questionnaire and visit
Secondary outcomes
1
Description
Quality of Life
Timepoint
first visit snd 8 Week after treatment
Method of measurement
dermatology Quality Life Index
2
Description
Complications
Timepoint
8 Week after treatment
Method of measurement
interview
3
Description
tolerance of treatment and satisfaction
Timepoint
8 Week after treatment
Method of measurement
interview
Intervention groups
1
Description
Intervention group: For the first group of patients, treatment includes only antihistamines.Two antihistamines is given twice daily and the type of them is prescribed based on the patient's condition and tolerance.These antihistamines are selected from cetirizine, desloratadine (neotadine) and fexofenadine. In addition, two lactocare capsules are prescribed too which are containing two probiotics.
Category
Treatment - Drugs
2
Description
Control group: The second group of patients only received antihistamines. Two antihistamines is given twice daily and the type of them is prescribed based on the patient's condition and tolerance.These antihistamines are selected from cetirizine, desloratadine (neotadine) and fexofenadine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool-E-Akram hospital
Full name of responsible person
Shokoufe Sharifi
Street address
Rasoul-E-Akram Hospital, Maziar Mansouri street, Sattarkhan street, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2528
Email
sharifishokoufeh67@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Abbas Motevalian
Street address
Rasoul-E-Akram Hospital, Maziar Mansouri street, Sattarkhan street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
sharifishokoufeh67@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Shokoufeh Sharifi
Position
Dermatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Rasoul-E-Akram Hospital, Maziar Mansouri street, Sattarkhan street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 912 343 1408
Email
sharifishokoufeh67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shokoufeh Sharifi
Position
Dermatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Rasoul-E-Akram Hospital, Maziar Mansouri street, Sattarkhan street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6435 2528
Email
sharifishokoufeh67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Javad Balasi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 26 3256 7229
Email
Javadbalasi8@gmail.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
All potential data can be shared after publication of result
When the data will become available and for how long
At the end of data collection period until the publication of results
To whom data/document is available
Only doctors and medical students
Under which criteria data/document could be used
Only when people intend to research about this topic
From where data/document is obtainable
To the scientific and executive members of the project
What processes are involved for a request to access data/document
Communicate with the scientific and executive authorities of the project - Submiting their official letter from research centers -using the patient's information only at designated center - Submiting their final report obtained by information.