Protocol summary

Summary
The objective of this study was evaluation of the effect of "steroid with omega3" and "steroid" on the treatment of psoriasis. The study encompasses all patients with psoriasis referring to the Besat Hospital of Sanandaj in 2008. Study sample included 70 patients that were divided into intervention and control groups based on randomized blocking method. Two groups were compared for response to treatment 3 weeks after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903162840N2
Registration date: 2010-06-24, 1389/04/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-06-24, 1389/04/03
Registrant information
Name
Roksana Yaghmaee
Name of organization / entity
Kurdistan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1328 5910
Email address
ryaghmaee@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2008-03-19, 1386/12/29
Expected recruitment end date
2009-03-20, 1387/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of omega-3 consumption on the treatment of psoriasis
Public title
The relation between fish oil consumption and treatment of psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with psoriasis diagnosis. Exclusion criteria: history of metabolic diseases, Cushing's disease, AIDS disease, sever psoriasis, pregnancy, lactation, present history of other drugs consumption.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Review Commiitee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran St.
City
Sanandaj
Postal code
Approval date
empty
Ethics committee reference number
پ14پ9045

Health conditions studied

1

Description of health condition studied
psoriasis
ICD-10 code
L40.0
ICD-10 code description
Psoriasis vulgaris

Primary outcomes

1

Description
redness, itching and exfoliation of the lesions
Timepoint
1 month
Method of measurement
observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: topical steroid 2 times/day for one month and omega3 drug 2 times/day for one month
Category
Treatment - Drugs

2

Description
Control group: topical steroid 2 times/day for one month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Street address
Keshavarz St.
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Ataollah Haydari
Street address
Pasdaran St.
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Roksana Yaghmaee
Position
Dermatologist, Assistant proffessor of dermatology department
Other areas of specialty/work
Street address
Dermatology clinic, Besat Hospital, Keshavarz St.
City
Sanandaj
Postal code
Phone
+98 87 1328 5913
Fax
Email
ryaghmaee@muk.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Roksana Yaghmaee
Position
Dermatologist
Other areas of specialty/work
Street address
Dermatology clinic , Besat Hospital, Keshavarz St.
City
Sanandaj
Postal code
Phone
+98 87 1328 5913
Fax
Email
ryaghmaee@muk.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr. Roksana Yaghmaee
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...