The purpose of this study is to evaluate the efficacy of autologous plasma therapy on clinical symptoms of Chronic Spontaneous Urticaria. The design of this study is clinical trial, before and after, on patients suffering from two forms of idiopathic and autoimmune of chronic spontaneous urticaria.
Major inclusion criteria are urticaria for more than 2 months; Age over than 15 year old; Consent to participate in the study; Negative Prick skin test for common inhalation and food allergens and normal findings in Lab data such as CBC (Complete Blood Count), ANA (Antinuclear antibody), ESR (Erythrocyte Sedimentation Rate), LFT (Liver Function Test), U/A (Urine Analysis) and S/E (Stool Exam). Major exclusion criteria are Pregnancy; Physical urticaria; Use of corticosteroid and immunosuppressive agents during the last 6 weeks; Use of drugs other than antihistamine and other systemic diseases.
The patients will be gathered from Allergy Clinic in Bushehr Martyrs Hospital in Persian Gulf due to the history and clinical symptoms. Then they will be divided into idiopathic and autoimmune type of the disease after the autologous plasma skin test.
After obtaining consent from participants in the study, patients will be treated with autologous plasma for 10 weeks. For evaluating the clinical improvement, the patients will be examined for the disease severity and activity before the treatment, every week during the treatment and one week after the treatment with DLQI (Dermatology Life Quality Index) and TSS (Total Symptoms Score) index. After the treatment evaluating the clinical improvement will be due to DLQI and TSS changes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040627260N1
Registration date:2016-05-10, 1395/02/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-10, 1395/02/21
Registrant information
Name
Afshin Shirkani
Name of organization / entity
Faculty of Medicine. Bushehr University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 4044
Email address
a.shirkani@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences, Student Research Committee
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial on efficacy of autologous plasma therapy on clinical symptoms of Patients with Chronic Spontaneous Urticaria Compared with no treatment
Public title
Efficacy of autologous plasma therapy on clinical symptoms of Chronic Spontaneous Urticaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are urticaria for more than 2 months; Age over than 15 year old; Consent to participate in the study; Negative Prick skin test for common inhalation and food allergens and normal findings in Lab data such as CBC (Complete Blood Count), ANA (Antinuclear antibody), ESR (Erythrocyte Sedimentation Rate), LFT (Liver Function Test), U/A (Urine Analysis) and S/E (Stool Exam).
Exclusion criteria are Pregnancy; Physical urticaria; Use of corticosteroid and immunosuppressive agents during the last 6 weeks; Use of drugs other than antihistamine and other systemic diseases.
Age
From 15 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
Salman Farsi Street, Bahmani, Medical Sciences Campus, First Floor, Bushehr, Iran
City
Bushehr
Postal code
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
ir.bpums.rec.1394.104
Health conditions studied
1
Description of health condition studied
Chronic Spontaneous Urticaria
ICD-10 code
L50.8
ICD-10 code description
Other urticaria (Urticaria: chronic, recurrent periodic)
Primary outcomes
1
Description
Qualitative clinical symptoms of urticaria
Timepoint
Before the treatment, every week during the treatment and one week after the treatment
Method of measurement
Changes in DLQI (Dermatology Life Quality Index)
Secondary outcomes
1
Description
Quantitative clinical symptoms of urticaria
Timepoint
Before the treatment, every week during the treatment for 10 weeks and one week after the treatment
Method of measurement
Changes in TSS (Total Symptoms Score) index
Intervention groups
1
Description
Patients will be divided into idiopathic and autoimmune forms of urticaria after the autologous plasma skin test. After consent to participate in the study, 5cc of brachial vein blood will be sampled first. Then we perform intradermal injection of equal measure from 0.1 cc of patient's centrifuged serum, histamine as a positive control and 0.9 % saline as a negative control at a distance of 3-5 cm from each other in the forearm and in the area that is free of rash in the past 48 hours with insulin syringes. Autologous plasma skin test is considered positive when after 30 minutes the swelling and redness diameter of serum injection area is equal or more than 1.5 mm greater than the swelling and redness of negative control injection site (normal saline). In order to treat with autologous plasma, we will take 5 ml of blood from the brachial vein using heparinized 10 ml sterile Falcon tubes from the subjects in Allergy Clinic in Bushehr Martyrs Hospital in Persian Gulf in every week for 10 weeks. Patients' plasma will be separated by centrifugation at 1000 rpm for 10 minutes and 2 cc of it will be injected deep intramuscular in gluteal or arms area alternatively.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy Clinic in Bushehr Martyrs Hospital in Persian Gulf
Full name of responsible person
Afshin Shirkani
Street address
Beginning Taleghani Ave. Azadi Square. Bushehr Martyrs Hospital in Persian Gulf. Bushehr. Iran.
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research of Bushehr University of Medical Sciences
Full name of responsible person
Soodabeh Zendeh Boodi
Street address
Salman Farsi Street, Bahmani, Medical Sciences Campus, First Floor, Bushehr, Iran
City
Bushehr
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 of Bushehr 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
Faculty of Medicine. Bushehr University of Medical Sciences.
Full name of responsible person
Afshin Shirkani
Position
Fellow of asthma, allergies and immunodeficiency diseases
Other areas of specialty/work
Street address
Faculty of Medicine. Bushehr University of Medical Sciences.Moallem St. Bushehr. Iran.
City
Bushehr
Postal code
7514633341
Phone
+98 77 3345 5388
Fax
Email
a.shirkani@bpums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Medicine. Bushehr University of Medical Sciences.
Full name of responsible person
Afshin Shirkani
Position
Fellow of asthma, allergies and immunodeficiency diseases
Other areas of specialty/work
Street address
Faculty of Medicine. Bushehr University of Medical Sciences.Moallem St. Bushehr. Iran.
City
Bushehr
Postal code
7514633341
Phone
+98 77 3345 5388
Fax
Email
a.shirkani@bpums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Medicine. Bushehr University of Medical Sciences.
Full name of responsible person
Milad Shamshirkar
Position
Medical Intern
Other areas of specialty/work
Street address
Faculty of Medicine. Bushehr University of Medical Sciences.Moallem St. Bushehr. Iran.
City
Bushehr
Postal code
7514633341
Phone
00
Fax
Email
milad_anzalichi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)