Studying the efficacy of a topical formulation containing aloe vera, white willow and avocado on relieving psoriasis symptoms
Design
Clinical trial without control group, unblinded, in phase 2 on 15 patients
Settings and conduct
Phase 2 clinical trials of efficacy and safety in 15 patients with mild to moderate psoriasis including men and women aged 19 to 59 years after their deliberate consent the exact location of the lesion is examined in constant certain light and camera conditions. Then the itching and burning rate of the selected lesions is graded from 0 to 10 by the patient. (0: no pain and itching (pruritis) and 10: maximum itching and burning) and psi score of the lesion is determined and recorded by the researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria: male or female volunteers with mild to moderate psoriasis patients between 19 and 59 years old healthy physical condition with deliberate consent
Exclusion criteria: having any systemic disease that affects the skin-using any topical or oral product to treat psoriasis in the last 4 weeks-using moisturizers during the study-any chemicals such as solvents contact during the study without informing the researchers-patients suffering cancer-pregnant and lactating women
Intervention groups
.
Main outcome variables
Changing in pruritis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160306026938N9
Registration date:2021-11-12, 1400/08/21
Registration timing:prospective
Last update:2021-11-12, 1400/08/21
Update count:0
Registration date
2021-11-12, 1400/08/21
Registrant information
Name
Mahdi Vazirian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6412 1223
Email address
vazirian_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the efficacy of a Topical formulation based on Aloe vera, Salix alba and Persea americana on relieving Psoriasis symptoms
Public title
Effect of Aloe vera, white willow and avocado on relieving psoriasis symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate psoriasis
Healthy physical condition
Patient's deliberate consent
Exclusion criteria:
Having any systemic disease that affects the skin
Using any topical or oral product to treat psoriasis in the last 4 weeks
Using moisturizers during the study
Any chemicals such as solvents contact during the study without informing the researchers
Patients suffering cancer
Pregnant and lactating women
Age
From 19 years old to 59 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qods street corner, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-10-20, 1400/07/28
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.800
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
The level of burning and itching
Timepoint
2 and 4 weeks after receiving the medicine
Method of measurement
patient questionnaire and psi score
Secondary outcomes
1
Description
PSI score
Timepoint
At the beginning of the intervention and then, 2 and 4 weeks after receiving the medicine
Method of measurement
measurement of the erythema, scaling and induration of the skin
Intervention groups
1
Description
Intervention group: Intervention group: the patient will use the topical gel twice daily on affected areas.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center of Research and Training in Skin Diseases and Leprosy
Full name of responsible person
Dr. Saman Ahmad Nasrollahi
Street address
No. 415, Nader Ave. corner, Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 0880
Email
samannasrol@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-chancellor of research and technology
Street address
Central organization of Tehran university of medical sciences, corner of Ghods Ave., Keshavarz
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Vazirian
Position
PhD of Pharmacognosy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6412 1223
Fax
+98 21 6695 4706
Email
vazirian_m@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Vazirian
Position
PhD of Pharmacognosy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6412 1223
Fax
+98 21 6695 4706
Email
vazirian_m@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Vazirian
Position
PhD of Pharmacognosy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6412 1223
Email
Vazirian_m@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Data would be accessible in related dissertation
When the data will become available and for how long
The onset of access from 2021
To whom data/document is available
everyone
Under which criteria data/document could be used
The documents could be accessible in case of further experiments
From where data/document is obtainable
Iran, Tehran, Tehran University of Medical Sciences, Faculty of Pharmacy, Dr. Mahdi Vazirian
What processes are involved for a request to access data/document