Comparison of the complications and efficacy of topical clobetasol ointment with salvia officinalis ointment in the treatment of plaque psoriasis patients
Determining the complications and efficacy of topical clobetasol ointment with salvia officinalis ointment in the treatment of plaque psoriasis
Design
Randomised, superiority, parallel group trial with non blinded outcome assessment, 2 groups , 82 patients. Randomisation was centralised with designed randomisation table
Settings and conduct
Shahid mohammadi hospital skin clinic
Participants/Inclusion and exclusion criteria
Plaque psoriasis patients who come to shahid mohammadi hospital skin clinic
Intervention groups
Group A: 41 plaque psoriasis patients recieve topical clobetasol ointment
Group B: 41 plaque psoriasis patients recieve salvia officinalis ointment
Main outcome variables
A new medical invention for plaque psoriasis treatment
Discontinuation of topical clobetasol complications
Cost reduction of medical care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210202050214N1
Registration date:2021-02-07, 1399/11/19
Registration timing:prospective
Last update:2021-02-07, 1399/11/19
Update count:0
Registration date
2021-02-07, 1399/11/19
Registrant information
Name
Amirhossein Mosalman haghighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 6994
Email address
amrhosnmosalman@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the complications and efficacy of topical clobetasol ointment with salvia officinalis ointment in the treatment of plaque psoriasis patients
Public title
Effect of salvia officinalis in treatment of psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Plaque psoriasis patients
Ability to follow up patients
Not use other treatments
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sample
Blinding (investigator's opinion)
Not 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 Bandar Abbas University of Medical Sciences
Street address
Shahid mohammadi hospital ,Jomhuri Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2021-01-11, 1399/10/22
Ethics committee reference number
1399.489.IR.HUMS.REC
Health conditions studied
1
Description of health condition studied
Plaque psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
Measuring patch scale size
Timepoint
Measuring patch scales every two weeks for a maximum two months
Method of measurement
Ruler
Secondary outcomes
1
Description
Measuring erythema eara size
Timepoint
Every two weeks until for a maximum two months
Method of measurement
Ruler
Intervention groups
1
Description
Intervention group: In this group every patient receives salvia officinalis ointment 3 times a day for a maximum 2 months , in average 300 miligrams salvia officinalis ointment %3 which contains glycerin ,eucerin , methylparaben that will be produced at hormozgan university laboratory
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid mohammadi hospitsl
Full name of responsible person
amirhossein mosalman haghighi
Street address
jomhuri blvd,Shahid mohammadi hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 6994
Email
amrhosnmosalman@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hesam alizade
Street address
Shahid mohammadi hospital, jomhuri Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 7192
Email
alizade.h2000@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Amirhossein Mosalman haghighi
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shahid mohammadi research institute,shahid mohammadi hospital,jomhoori eslami ave, bandar abbas town
City
Bandar abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 6994
Fax
Email
amrhosnmosalman@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Amirhossein Mosalman haghighi
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shahid mohammadi research institute,shahid mohammadi hospital,jomhoori eslami ave, bandar abbas town
City
Bandar abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 6994
Fax
Email
amrhosnmosalman@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Amirhossein Mosalman haghighi
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shahid mohammadi research institute,shahid mohammadi hospital,jomhoori eslami ave, bandar abbas town
City
Bandar abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 6994
Fax
Email
amrhosnmosalman@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available