Determination effect of a topical cream containing Chelidonium Majus and Hyoscyamus Niger with Propolis on Psoriasis
Design
The randomized clinical trial with an intervention and a control group, double-blind, phase 3 on 88 patients
Settings and conduct
A double-blind study is performed on 88 psoriasis patients in Shahid Beheshti of Kashan hospitals. The doctor and the patient do not know the type of treatment. The patients receive topical cream containing Chelidonium majus and Hyoscyamus niger with Propolis for 6 weeks. The duration of each cream will be 6 days and the treatment will be done three times a day.
Participants/Inclusion and exclusion criteria
Inclusion criteria: known case of psoriasis; Clinical judgment of the specialist physician based on receiving the product; Patients with psoriasis during 3 months, the age range of 18 to 85 years.
Exclusion criteria : Existence of any history of allergy to any herbal product; pregnancy for females.
Intervention groups
he intervention group is included 44 psoriasis patients . During three weeks, topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger with 2 grams of Propolis is used. The duration of each cream will be 6 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
Main outcome variables
Quantitative and qualitative evaluation of wounds extent and redness of the skin and the extent of involvement of different parts of the body and itching; expression of TNF-α, IL-17 gene.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047462N4
Registration date:2022-01-15, 1400/10/25
Registration timing:registered_while_recruiting
Last update:2022-01-15, 1400/10/25
Update count:0
Registration date
2022-01-15, 1400/10/25
Registrant information
Name
morteza kosari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5434 6622
Email address
yeganehbadi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-15, 1400/10/25
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of topical cream containing processes of Chelidonium majus and hyoscyamus niger with propolis on psoriasis
Public title
Effect of Chelidonium majus and hyoscyamus niger with propolis on psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
known case of psoriasis
Clinical judgment of the specialist physician based on receiving the product
Patients with psoriasis during 3 months, and are in the age range of 18 to 85 years
Exclusion criteria:
Existence of any history of allergy to any herbal product
pregnancy for females
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Samples with the help of Sealed Envelope Ltd. 2017 is divided into two groups of intervention and control in the form of blocks of 4 and 6 (selection of these blocks randomly). Each of these blocks has an equal number of control and intervention groups. A special number is assigned to each prescription drug [intervention and control (placebo)]. The doctor and the patient are not aware of the medication or placebo, and only the epidemiologist, as one of the executors, knows the number or code on registered on creams.
Blinding (investigator's opinion)
Double blinded
Blinding description
A cream that has an active ingredient with a cream that does not have a substance and is used as a placebo is completely identical in terms of the shape and size of the container, and the solution themselves do not differ in terms of color, and are completely indistinguishable. The important point is that the patient is told that the topical cream used for the patient may be medication or medication. Clinicians and patients will be blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd, Shahid Beheshti Hospital, University of Medical Sciences, Kashan, Iran.
City
Kashan
Province
Isfehan
Postal code
87159/81151
Approval date
2021-04-28, 1400/02/08
Ethics committee reference number
IR.KAUMS.REC.1400.002
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
PASI Score
Timepoint
At the beginning of the study, 4, 7, 14, 28 and 40 days after treatment
Method of measurement
Evaluated quantitatively and qualitatively of wounds extent and redness of the skin and the extent of involvement of different parts of the body and itching .
2
Description
Expression of TNF-α, IL-17 gene
Timepoint
After 40 days
Method of measurement
Real Time PCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group is included 44 patients with psoriasis. During three weeks, topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger with 2 grams of Propolis is used. The duration of each cream will be 6 days and the treatment will be done tree a day. The patient receives a maximum of 3 creams during the treatment period.
Category
Treatment - Drugs
2
Description
Control group: Topical cream with no active ingredients is used for three weeks. The duration of use of each cream will be 6 days. The patient receives a maximum of 3 creams during the treatment period.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Kashan
Full name of responsible person
Morteza Kosari
Street address
Ghotb Ravandi Blvd, Shahid Beheshti hospital of Kashan
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Ghotbe Ravandi Blvd, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
20
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
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
kosarimorteza12@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 87 1598 8141
Email
kosarimorteza12@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
kosarimorteza12@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not 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
Information about participants such as age, gender, level of education and employment will be reported. The treatment protocol and the duration of treatment process will be reported. Therapeutic results of the product and possible side effects will be reported.
When the data will become available and for how long
The start of the access period will be 6 months after patent presentation or 1 months after article publication.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutes.
What processes are involved for a request to access data/document
This access will be based on the treatment protocol in patients and treatment results, and includes effective ingredients and how to make the privacy cream of the project implementers. We will try to respond to researchers as soon as possible.