The purpose of this study was to assess the response to treatment of nigella sativa oil and comparison with fish oil in vitiligo patients. This study was conducted as a randomized double-blind, single center. 52 known cases of vitiligo, not using of nigella sativa or fish oil during last 3 months, no pregnancy for females were recruited. These patients selected from hospitalized vitiligo patients referred to Dermatology clinic of Ahvaz Imam Khomeini hospital. Drugs were utilized by patients in 6 months during 22 June and 21 December 2011. They were asked 7 times after starting the study, first at the baseline and then every month till sixth months, for theire symptoms due to lesions based on a Vitiligo Area Scoring Index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201025069N5
Registration date:2012-01-06, 1390/10/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-06, 1390/10/16
Registrant information
Name
Alireza Ghorbani Birgani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 61 1229 8173
Email address
ghorbani@iaug.ac.ir
Recruitment status
Recruitment complete
Funding source
Gachsaran Islamic Azad University
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Nigella Sativa and Fish Oil in Vitiligo
Public title
Efficacy of Nigella Sativa Oil and Fish Oil in Vitiligo Patients in Iran
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: known case of vitiligo, not using of nigella sativa or fish oil during last 3 months, no pregnancy for females. Exclusion criteria:pregnancy for females,using of nigella sativa or fish oil during last 3 months.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University
Street address
Academic Complex (Site)-Islamic Azad University
City
Gachsaran
Postal code
32356
Approval date
2011-05-20, 1390/02/30
Ethics committee reference number
467
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Vitiligo
Timepoint
before intervention and every month for sixth months
Method of measurement
Vitiligo Area Scoring Index
Secondary outcomes
empty
Intervention groups
1
Description
Nigella sativa oil, 100 gram twice a day for 6 months in first intervention group
Category
Treatment - Drugs
2
Description
Fish oil, 100 gram twice a day for 6 months in second intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Imam Khomeinie Hospital
Full name of responsible person
Alireza Ghorbani Birgani
Street address
Azadegan Ave-Imam Khomeinie Hospital
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gachsaran Islamic Azad University
Full name of responsible person
Saman Moosavian
Street address
Academic Complex (Site)-Islamic Azad University
City
Gachsaran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gachsaran Islamic Azad University
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
Gachsaran Islamic Azad University
Full name of responsible person
Saman Moosavian
Position
Faculty Member/Master
Other areas of specialty/work
Street address
Academic Complex (Site)-Islamic Azad University
City
Gachsaran
Postal code
32356
Phone
+98 74 2333 4607
Fax
Email
info@iaug.ac.ir
Web page address
www.iaug.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gachsaran Islamic Azad University
Full name of responsible person
Alireza Ghorbani Birgani
Position
Faculty Member/Master
Other areas of specialty/work
Street address
Academic Complex (Site)-Islamic Azad University
City
Gachsaran
Postal code
75817
Phone
+98 74 2333 4600
Fax
+98 61 1270 2090
Email
alenc5@gmail.com
Web page address
www.iaug.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gachsaran Islamic Azad University
Full name of responsible person
Saman Moosavian
Position
Faculty Member/Master
Other areas of specialty/work
Street address
Academic Complex (Site)-Islamic Azad University
City
Gachsaran
Postal code
32356
Phone
+98 74 2333 4607
Fax
+98 74 2333 4751
Email
info@iaug.ac.ir
Web page address
www.iaug.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)