Determination of serum levels of Anti TPO and Anti Tg before starting treatment and 3 month after starting treatment with Colchicine in chronic urticaria patients
Record information about patient examinations based on the UAS7 and CU_Q2oL questionnaire before starting treatment and 3 month after starting treatment with Colchicine in chronic urticaria patients
Design
A double blind randomized clinical trial with parallel groups
Settings and conduct
50 patients with chronic urticaria will be considered as the study population referred to the allergy clinic of Imam Reza Clinic in Shiraz. Informational examinations of patients based on 2 standard questionnaires CU_Q2oL and UAS with questioner will be recorded in 2 steps (before the intervention, and 3 months after the intervention). Then, blood samples are taken from all patients with chronic urticaria , including Anti-TPO and Anti-TG serum levels (before the intervention, and 3 months after the intervention). Patients were randomly assigned to 2 groups based on their case number was even or odd, control group (standard treatment, including Fexofenadine and Doxepin) and the intervention group (including standard treatment + oral Colchicine at a dose of 1 mg daily for 3 months). The results will be recorded and finally compared with the results before the intervention.
Participants/Inclusion and exclusion criteria
Including patients with chronic urticaria with positive thyroid autoantibodies in the age range of 20 to 70 years ; excluding below 20 age, pregnant and lactating women, side effect of Colchicine
Intervention groups
The control group is treated with Fexofenadine and Doxepin for 3 months.
The intervention group will receive Fexofenadine, Doxepin and Colchicine 1 mg for three months.
Main outcome variables
Reducing the title of autoantibodies and the symptoms of patients with urticaria after treatment with Colchicine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200406046967N1
Registration date:2020-04-10, 1399/01/22
Registration timing:prospective
Last update:2020-04-10, 1399/01/22
Update count:0
Registration date
2020-04-10, 1399/01/22
Registrant information
Name
Masroor Babaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3649 9543
Email address
meisam.sargazi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of colchicine on the antithyroid antibody titer in chronic urticaria patient.
Public title
Effect of Colchicine in treatment of chronic urticaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic urticaria in the age range of 20 to 70 years
Exclusion criteria:
pregnant and lactating females
Patients with Physical Urticaria and Vasculitis Urticaria
Patients with Colchicine-induced drug side effects
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
This study is based on a Random number table. In this study, table numbers are read from above and to the right.
Couples' numbers are for the first group (intervention) and individual numbers are for the second group (control).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients know that they are participating in the study and have entered the study consciously and with prior written consent, but do not know exactly which group they are in.
he main researchers of the study are unaware of the type of medication used for each patient and how the patients are assigned to the groups and which group each patient is in.
Data collection and follow-up officials are unaware of the type of medication used for each patient and how the patients are assigned to the groups and which group each patient is in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
"Percentage of people with chronic urticaria who have autoimmune thyroiditis"
Timepoint
"Measurement of thyroid autoantibodies at the beginning of the study (before the intervention) and 3 months after taking colchicine"
Method of measurement
"Peripheral blood sample"
Secondary outcomes
1
Description
" The urticaria score in the Urticaria Activity Score 7 questionnaire"
Timepoint
" Comparison of the average total score of the Urticaria Activity Score 7 questionnaire in the study groups at the beginning of the study and 3 months after taking colchicine"
Method of measurement
" Urticaria Activity Score 7 questionnaire"
2
Description
"The urticaria score in the Chronic Urticaria Quality of Life questionnaire"
Timepoint
Comparison of the average total score of the Chronic Urticaria Quality of Life questionnaire in the study groups at the beginning of the study and 3 months after taking colchicine"
Method of measurement
"Chronic Urticaria Quality of Life questionnaire"
Intervention groups
1
Description
Intervention group: "The first intervention group of Fexofenadine tablets 120 mg once daily for 3 months from Saha Pharmaceuticals, Doxepin tablets 10 mg once daily for 3 months from Razak Pharmaceuticals and Colchicine tablets 1 mg once daily for 3 months from Modava Pharmaceuticals"
Category
Treatment - Drugs
2
Description
Intervention group: "The second intervention group of Fexofenadine tablets 120 mg once daily for 3 months from Saha Pharmaceuticals, Doxepin tablets 10 mg once daily for 3 months from Razak Pharmaceuticals" ;
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Clinic
Full name of responsible person
Masroor Babaeian
Street address
Imam Reza Specialized and Subspecialty Clinic, next to Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
71473771348
Phone
+98 71 3212 7000
Fax
+98 71 3647 4673
Email
motahari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Hesam Nabavi Zadeh
Street address
Pediatric's Department Office, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Fax
+98 71 3647 4332
Email
nemazee_inf@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?