This study in a single-blind clinical trial design, aimed to investigate the effects of levothyroxine tablets in patients with chronic pruritus who are Anti TPO antibody positive at the same time. Among the patients referred to the Allergy Clinic with chief complaint of pruritus which lasts at least for 3 menthes in order of matching the inclusion criteria, 72 patients as two groups of 36 subjects will enroll the study. Inclusion criteria included chronic pruritus, Anti TPO antibody positive, age over 20 years and less than 60 years and the main exclusion criteria included a history of taking thyroid medication in the past six months and pregnant women and lactating mothers. The first group will be treated with Levothyroxine and antihistamine tablets while the second group will only be treated with antihistamines. Patients will be treated for 12 weeks and they will be visited once a month during this period to follow healing and treatment effects. Patients healing will be defined as the loss of pruritus.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014112613612N3
Registration date:2015-11-06, 1394/08/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-06, 1394/08/15
Registrant information
Name
Farzad Najafipour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
najafipourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of levothyroxin on patients with chronic pruritus and positive Anti- TPO
Public title
The effect of levothyroxin on patients with chronic pruritus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with chronic pruritus (over 3 months); patients with positive Anti TPO antibody; patients with 20 to 60 years old ; patients who did not take systemic steroids in the past six months; patients who did not take levothyroxin or methimazole in the past six months.
The exclusion criteria: patients younger than 20 years old or older than 60 years; patients who took systemic corticosteroids, levothyroxin or methimazole in the last six months; lactating mothers or pregnant women.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq.
City
Tabriz
Postal code
Approval date
2014-11-13, 1393/08/22
Ethics committee reference number
93117
Health conditions studied
1
Description of health condition studied
chronic pruritus
ICD-10 code
L29.9
ICD-10 code description
Pruritus, unspecified
Primary outcomes
1
Description
Patients pruritus
Timepoint
At baseline and after 3 months of treatment
Method of measurement
Quastionnaire
Secondary outcomes
1
Description
Decrease in severity of pruriency in patient with pruritus and Anti TPO+
Timepoint
After 3 month
Method of measurement
Via VAC questionnaire
Intervention groups
1
Description
In the first group tablet levothyroxin 100 micro gram daily and tablet loratadin 10 milligram daily will be prescribed.
Category
Treatment - Drugs
2
Description
In the second group only tablet loratadin 10 milligram daily will be prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy Clinic Golgasht infirmary
Full name of responsible person
Dr.Mahnaz Sadeghi Shabestari
Street address
Golgasht St.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Farzad Najafipour
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Avenue, Daneshgah Square Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Sadeghi Shabestari
Position
Immunologist Allergist /Associated Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Tabriz Department Of Internal Medicine
City
Tabriz
Postal code
Phone
+98 41352622505
Fax
Email
sadeghim@tbzmed.ac.irmabbasnazhad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farzad Najafipour
Position
Assistant Professor of Endocrinology and Metabolic Diseases
Other areas of specialty/work
Street address
Srourbakhsh Alley, Abresan, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 4531
Fax
Email
najafipourf@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz medical university
Full name of responsible person
Mohammad Khanmohammadi
Position
MD, Resident of Internal Medicine
Other areas of specialty/work
Street address
Srourbakhsh Alley, Abresan
City
Tabriz
Postal code
Phone
00
Fax
Email
mohammad1563@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)