comparison effects of two regimens: prednisolone plus cimetidine versus prednisolone plus colchicine in control of frequency and duration of fever episodes In the Periodic fever, Aphthous stomatitis, Pharyngitis and Adenitis in children referred to pediatric medical center
Evaluation and comparison of the effect of prednisolone + cimetidine and prednisolone + colchicine in the treatment of fever and frequency of attacks in PFAPA syndrome
Design
two intervention groups, parallel, triple blind, randomized"The response to treatment is evaluated by comparing the number of fever attacks and the duration of fever periods. Data analysis was performed by SPSS"
Settings and conduct
Children's Medical Center & Vali Asr Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Age of onset of symptoms from 1 year to 10 years of age
2. Absence of inflammatory or other rheumatic disease, simultaneously
3. No concomitant disease in which there are contraindications (prednisolone, cimetidine, colchicine). Exclusion criteria:
1. Causing any other rheumatic disease during treatment.
2. Changing the diagnosis of the patient during treatment based on laboratory or clinical symptoms.
3. Lack of proper follow-up and unwillingness to attend the study.
4. Use other treatments that affect the course of the disease, such as specific diets and herbal remedies.
Intervention groups
The study was performed on 80 children with PFAPA syndrome referred to the Pediatric Rheumatology Clinic between October 2019 and June 2020.Patients will be randomly divided into two groups of prednisolone plus cimetidine and prednisolone plus colchicine. The first group will be treated with prednisolone during fever and in addition to prednisolone, cimetidine will be given daily. In the second group, prednisolone is given for fever and will be given daily. The duration of the fever period and the number of fever attacks before and after the treatment are recorded in a questionnaire.Two visits will take over a period of 3 months
Main outcome variables
Duration of fever "Age" Number of fever attacks "Diagnosis of PFAPA" treatment regimen
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191222045847N1
Registration date:2020-02-11, 1398/11/22
Registration timing:registered_while_recruiting
Last update:2020-02-11, 1398/11/22
Update count:0
Registration date
2020-02-11, 1398/11/22
Registrant information
Name
Mahdieh Vahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 8051
Email address
mahvahedi_62@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison effects of two regimens: prednisolone plus cimetidine versus prednisolone plus colchicine in control of frequency and duration of fever episodes In the Periodic fever, Aphthous stomatitis, Pharyngitis and Adenitis in children referred to pediatric medical center
Public title
comparison effects of two regimens: prednisolone plus cimetidine versus prednisolone plus colchicine in control of frequency and duration of fever episodes In the Periodic fever, Aphthous stomatitis, Pharyngitis and Adenitis in children referred to pediatric medical center
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age of onset of symptoms from 1 year to 10 years of age 2. Absence of inflammatory or other rheumatic disease at the same time 3.there are No concomitant disease that this drugs contraindicated on it (prednisolone, cimetidine, colchicine).
Exclusion criteria:
Age
From 1 year old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization(given a block size of 4)
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participant, the researcher, the clinical supervisor and the analyzer are not aware of the intended drug intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of school of medicine-Tehran university of medical science
Street address
Deputy of Education, Seventh Floor, Central Organization of Tehran University of Medical Sciences, Qods Ave., Keshavarz Blvd., Tehran, Iran
City
tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-10-23, 1398/08/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.600
Health conditions studied
1
Description of health condition studied
PFAPA syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
frequency and duration of fever episodes in PFAPA
Timepoint
Before starting the study and 3 months later
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: PFAPA syndrome patients treated with prednisolone and cimetidine
Category
Treatment - Drugs
2
Description
Intervention group: PFAPA syndrome patients treated with prednisolone and colchicin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center Hospital
Full name of responsible person
Vahid Ziai
Street address
No.62 , Street Dr. Mohammad , End of Keshavarz Boulevard -
City
tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Email
cmc.tums@gmail.com
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex - Valiasr Hospital
Full name of responsible person
Reza raees karami
Street address
Street Dr. Mohammad , End of Keshavarz Boulevard -
City
tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad sahraeeyan
Street address
Sixth Floor, Vice Chancellor for Research and Technology, Qods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
medical University Tehran
Grant code / Reference number
۰
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahdieh Vahedi
Position
Pediatric Rheumatology Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Azadi st, Qanei Alley,No 10.
City
Tehran
Province
Tehran
Postal code
1457966768
Phone
+98 21 6692 8051
Fax
Email
mahvahedi_62@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdieh Vahedi
Position
Pediatric Rheumatology Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Azadi st, Qanei Alley,No 10.
City
Tehran
Province
Tehran
Postal code
1457966768
Phone
+98 21 6692 8051
Fax
Email
mahvahedi_62@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdieh Vahedi
Position
Pediatric Rheumatology Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Azadi st, Qanei Alley,No 10.
City
Tehran
Province
Tehran
Postal code
1457966768
Phone
+98 21 6692 8051
Fax
Email
mahvahedi_62@yahoo.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