The purpose of this study was to assess the response to treatment of berberine cream in psoriasis patients. This study was conducted as a randomized double-blind, single center. 60 known cases of psoriasis, not using of berberine cream during last 3 months, no pregnancy for females were recruited. These patients selected from hospitalized psoriasis patients referred to Dermatology clinic of Ahvaz Imam Khomeini hospital. Drugs were utilized by patients in 6 months during 23 July and 21 January 2011. They were asked 7 times after starting the study, first at the baseline and then every month till sixth months, for their symptoms due to lesions based on a Psoriasis Area Severity Index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201305069N6
Registration date:2012-02-22, 1390/12/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-22, 1390/12/03
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
2011-07-23, 1390/05/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Efficacy of Berberine and Placebo on Skin Lesions of Psoriasis Patients
Public title
The Efficacy of Berberine on Patients with Psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: known case of psoriasis, not using of berberine cream during last 3 months,
Exclusion criteria: pregnancy for females, sensitivity to components of barberry
Age
From 2 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
2011-11-11, 1390/08/20
Ethics committee reference number
498
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
Psoriasis
Timepoint
before intervention and every month for sixth months
Method of measurement
Psoriasis Area Severity Index
Secondary outcomes
empty
Intervention groups
1
Description
Berberine cream, 50 gram twice a day for 6 months in first intervention group
Category
Treatment - Drugs
2
Description
Placebo, 50 gram twice a day for 6 months in first 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
Ahvaz
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
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
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)