Evaluation of the effectiveness of topical formulation of Boswellia serrata extract compared to clobetasol in the treatment of psoriasis vulgaris; a randomized controlled clinical trial
Evaluation of the effectiveness of topical formulation of Boswellia serrata extract compared to clobetasol in the treatment of psoriasis vulgaris
Design
Two arm parallel groups randomized trial with the control group
Settings and conduct
The study will be performed in Sedigheh Tahereh Research Center of Isfahan. Patients with inclusion criteria will be randomly assigned to drug or control groups. The sample size is 22 patients. For patients in the drug group, a 10% boswellia Ointment will be applied for four weeks, while for patients of the control group, 0.05% clobetasol Ointment will be used for four weeks. Before and at the end of the intervention, the size of lesions according to BSA percentage and Psoriasis Area and Severity Index (PASI) score will be recorded for each Patient. Finally, the mentioned variables will be compared between the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mild psoriasis vulgaris in the areas of limbs and trunk; Mild psoriasis is defined as Involvement of a maximum of 10% of the body surface area (BSA)./ Exclusion criteria: 1-Incidence of other types of psoriasis (erythrodermic, guttate, ...) 2-Incidence of Facial or scalp psoriasis 3-Incidence of psoriatic arthritis 4-Receiving systemic anti-psoriasis treatment and phototherapy during last month 5-Receiving topical anti-psoriasis treatment during last two weeks 6-Autoimmune disorders 7-Incidence of other chronic skin disorders (pemphigus, eczema, dermatitis, lichen planus) 8-Infection in the lesion 9-Pregnancy 10-Lactation
Intervention groups
Intervention group: 10% boswellia Ointment, for 28 days Control group:
0.05% clobetasol Ointment, for 28 days
Main outcome variables
1- Change in the size of lesions according to BSA percentage Change at the end of the intervention 2- Change in the Severity of lesions according to PASI Change at the end of the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023282N23
Registration date:2022-09-13, 1401/06/22
Registration timing:prospective
Last update:2022-09-13, 1401/06/22
Update count:0
Registration date
2022-09-13, 1401/06/22
Registrant information
Name
Rasool Soltani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7067
Email address
soltani@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-21, 1401/09/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of topical formulation of Boswellia serrata extract compared to clobetasol in the treatment of psoriasis vulgaris; a randomized controlled clinical trial
Public title
Evaluation of the effectiveness of Boswellia serrata in the treatment of psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild psoriasis vulgaris in the areas of limbs and trunk; Mild psoriasis is defined as Involvement of a maximum of 10% of the body surface area (BSA).
Exclusion criteria:
Incidence of other types of psoriasis (erythrodermic, guttate, ...)
Incidence of Facial or scalp psoriasis
Incidence of psoriatic arthritis
Receiving systemic anti-psoriasis treatment and phototherapy during last month
Receiving topical anti-psoriasis treatment during last two weeks
Autoimmune disorders
Incidence of other chronic skin disorders (pemphigus, eczema, dermatitis, lichen planus)
Infection in the lesion
Pregnancy
Lactation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
All the arrangements of the two groups will be drawn in pairs in quadruple blocks and each block will be numbered from 1 to the end. Using a table of random numbers, the blocks are selected in order and based on the arrangement of that block, patients will be divided into one of two groups according to the order of admission.
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 Isfahan University of Medical Sciences
Street address
Hezar-Jerib Avenue, Vice-chancellery for research, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-08-23, 1401/06/01
Ethics committee reference number
IR.MUI.MED.REC.1401.205
Health conditions studied
1
Description of health condition studied
Psoriasis vulgaris
ICD-10 code
L40.0
ICD-10 code description
Psoriasis vulgaris
Primary outcomes
1
Description
change in Psoriasis Area and Severity Index (PASI) Before the intervention and at the end of the intervention
Timepoint
Before the intervention, 28 days after the start of intervention
Method of measurement
The online calculator that is available on the following website: https://www.mdcalc.com/calc/10182/psoriasis-area-severity-index-pasi
2
Description
Percentage change in body surface area (BSA) at the end of the intervention
Timepoint
Before the intervention, 28 days after the start of intervention
Method of measurement
chart
Secondary outcomes
1
Description
Intensity of itching
Timepoint
Before the intervention, 28 days after the start of intervention
Method of measurement
Use Visual Analogue Scale (VAS) from 0 (No itchy) to 10 (Extremely itchy) by patients
2
Description
Proportion of people with PASI 50 (decrease of at least 50% in the PASI score) at the end of the intervention
Timepoint
Before the intervention, 28 days after the start of intervention
Method of measurement
Observation
3
Description
Proportion of people with complete recovery (PASI 90) at the end of the intervention
Timepoint
Before the intervention, 28 days after the start of intervention
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: 10% boswellia Ointment, made by Isfahan University of Medical Science, School of Pharmacy,twice a day, for 28 days
Category
Treatment - Drugs
2
Description
Control group: 0.05% clobetasol Ointment,twice a day, for 28 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Dermatology and Leishmaniasis Research Center Clinic
Full name of responsible person
Rasool Soltani
Street address
Khorram Ave. Skin and Leishmaniasis Research Center
City
isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3337 3736
Email
sdlrc@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Hezar-Jerib Ave.
City
isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD