The effect of cream containing Artemisia plant extract on psoriasis patients.
Design
This study is a placebo-controlled randomized double-blind clinical trial, and its target population is 30 patients aged 15 to 50 with psoriasis who refer to a specialist.
After making creams containing artemisia extract and creams containing Clobetasol (the main drug) and comparing the organoleptic characteristics of both types of creams, including color and smell, the creams were packed in a completely similar package and one person outside the study Creams containing artemisia extract or cream Clobetasol-containing drugs are assigned one of two codes, A or B.
Settings and conduct
The herbal cream is 60 grams in the form of a tube and contain herbal extract.
The way to use Artemisia cream is that the patient is asked to apply an index finger size amount of cream on the knee lesion with dimensions of 5x10 square centimeters or a lesion with an area of about 50 square centimeters every night for 3 weeks. The doctor has specified and marked, put it on and leave it until the morning, and during this time do not use any other topical or non-topical anti-psoriasis products. Then it is evaluated based on the PASI criteria.
Participants/Inclusion and exclusion criteria
Psoriasis patients; 15 to 50 years old who are able to use the topical product; Personal willingness to cooperate in the plan and complete the written informed consent form.
Intervention groups
Intervention and control groups.
Each patient is given the main drug (Clobetasol cream) and the study drug (cream containing Artemisia extract), which is assigned one of the codes A or B in the blinding section.
Main outcome variables
redness of psoriasis rash; PASI number corresponding to each patient means the intensity index of the psoriasis area; The thickness and prominence of psoriasis rashes; flaking; level of conflict
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001157N20
Registration date:2023-03-29, 1402/01/09
Registration timing:prospective
Last update:2023-03-29, 1402/01/09
Update count:0
Registration date
2023-03-29, 1402/01/09
Registrant information
Name
Hasan Fallah Huseini
Name of organization / entity
Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26 3476 4010
Email address
fallah@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the safety and efficacy of Artemisia herbal cream product for the improvement and treatment of psoriasis skin patients
Public title
The effect of Artemisia herbal cream product on improving the symptoms of patients with psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with psoriasis.
15 to 50 years old who are able to use the topical product.
Personal desire to participate in the project and the signing of a written consent.
Exclusion criteria:
People who are allergic to plant extracts and Artemisia annua plant extract.
pregnant women.
Lactating women.
Patients treated for systemic psoriasis 3 months before and during the study.
Patients who have a history of malignant disease, taking anti inflammatory and immunosuppressive drugs.
Age
From 15 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups.
A random number table and block randomization method is used. In this method 60 eligible patients are assigned into 30 blocks of 2 patients. Then, each of the 2 patients in the block is randomly assigned to take herbal cream or standard cream, so that 30 patients assigned to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
After making creams containing artemisia extract and creams containing Clobetasol (the main drug) and comparing the organoleptic characteristics of both types of creams, including color and smell, the creams were packed in a completely similar package and one person outside the study Creams containing artemisia extract or creams containing Clobetasol are assigned one of the two codes A or B so that the patients, the project managers, the specialist doctor and the person in charge of data analysis do not know about the content of creams A or B during the study. .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics Committees of Islamic Azad University, Shahrood Branch
Street address
Islamic Azad University, Shahrood Branch
City
Shahrood
Province
Semnan
Postal code
3619943189
Approval date
2023-02-15, 1401/11/26
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1401.073
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40.0
ICD-10 code description
Psoriasis vulgaris
2
Description of health condition studied
Other psoriasis
ICD-10 code
L40.8
ICD-10 code description
Other psoriasis
3
Description of health condition studied
Moderate to severe psoriasis
ICD-10 code
L40.1
ICD-10 code description
Generalized pustular psoriasis
Primary outcomes
1
Description
Erythema (redness) of Psoriasis rashes.
Timepoint
At the beginning of the study (before the start of the intervention) and after three weeks (end of the study).
Method of measurement
Observation.
2
Description
PASI number suitable for each patient (severity index of the psoriasis area)
Timepoint
At the beginning of the study (before the start of the intervention) and after three weeks (end of the study).
Method of measurement
The software for calculating the severity index of psoriasis area version 2.7.1
3
Description
The thickness and prominence of psoriasis rashes.
Timepoint
At the beginning of the study (before the start of the intervention) and after three weeks (end of the study).
Method of measurement
Observation.
4
Description
Flaking.
Timepoint
At the beginning of the study (before the start of the intervention) and after three weeks (end of the study).
Method of measurement
Observation.
5
Description
level of conflict.
Timepoint
At the beginning of the study (before the start of the intervention) and after three weeks (end of the study).
Method of measurement
Ruler (cm).
6
Description
Intensity of itching.
Timepoint
At the beginning of the study (before the start of the intervention) and after three weeks (end of the study).
Method of measurement
Using a visual scale with scoring by patients from 0 (no itching) to 10 (the most severe itching).
7
Description
Patient satisfaction.
Timepoint
After completing the study.
Method of measurement
VAS index (visual analog scale) which is a 10-point scale and shows the quality of the patient in the form of quantity with numbers.
Secondary outcomes
1
Description
Side effects of the drug.
Timepoint
During the study.
Method of measurement
Questionnaire and specialized visit by a dermatologist.
Intervention groups
1
Description
Intervention group: for 3 weeks, the patients of this group used a 60-gram tube of plant extract cream containing artemisia extract, wheat germ oil, jojoba oil, avocado oil, and pomegranate seed oil every night for 3 weeks. They use it locally on the lesions specified by the doctor.
Category
Treatment - Drugs
2
Description
Control group: The patients of this group use the cream containing Clobetasol topically on the lesions specified by the doctor, every night for 3 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital of Shahrood
Full name of responsible person
Marjan Talebi
Street address
Imam Hossein Hospital., End Imam street.,
City
Shahrood
Province
Semnan
Postal code
3616951835
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
marjan.talebi@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahebali Manafi
Street address
Shahrood University blvd, Islamic Azad University, Shahrood branch
City
Shahrood
Province
Semnan
Postal code
3619943189
Phone
+98 23 3239 4279
Email
ali_manafi2005@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Nasrin Razavianzadeh
Position
Internal Medicine
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
University Blvd, Khatam al-Anbia hospital
City
Shahrood
Province
Semnan
Postal code
3619943189
Phone
+98 23 3223 1442
Fax
+98 23 3233 1876
Email
nasrinrazavianzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Homapharmed Company
Full name of responsible person
Mohammadreza Gholibeikian
Position
R & D
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 26, Nader Alley, North Jamalzadeh St, Enghelab Square
City
Tehran
Province
Tehran
Postal code
1418635643
Phone
+98 21 6276 9000
Fax
+98 21 6690 8071
Email
mgholibeikian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Golestan
Full name of responsible person
Amirhosein Firouzi
Position
Ph.D candidate of Phytochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Isolation and purification of natural products, herbal medicine
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Research results are published in the form of articles.
When the data will become available and for how long
The article will be published about six months after the completion of the project.
To whom data/document is available
There is no objection or prohibition for public use of the published article.
Under which criteria data/document could be used
The use of data with reference to the source is unrestricted.
From where data/document is obtainable
Nasrin Razavianzadeh University Blvd, Khatam al-Anbia hospital with 1000 Patient Beds, Shahrood Postal code: 3619943189 Phone: 09121731846 Email: nasrinrazavianzadeh@gmail.com
What processes are involved for a request to access data/document
To view the report of this research, after sending the request, the Vice Chancellor for Research of Islamic Azad University, Shahrood branch will follow up and inform.