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The impact of Florabile syrup on intensity (inflammation, plaque, and scaling) of Psoriasis rashes in patients aged 20 to 50 years.

Protocol summary

Study aim
Determination of the impacts of of Florabile syrup on the severity of Psoriasis rashes in patients between 20 to 50 years. Determination and comparison of the frequency of; Psoriasis rashes erythema, Psoriasis rashes plaque, Psoriasis rashes scaling and the frequency of BSA (Body Surface Area); surface of the patient's body that is involved by Psoriasis rashs, before and after the intervention. Determination and comparison of the average of PASI (Psoriasiss Area and Severity Index) of patients before and after the intervention.
Design
Clinical experiment of pre and post (self-control), single group and not blind.
Settings and conduct
Patients with Psoriasis who visited doctor in Iranian medical clinics at Al-zahra, Amin, and Kashani hospitals in Isfahan consumed Florabile syrup three spoons diluted with a glass of water one hour before lunch for a 30 days period; and also it was suggested to the patients that they are supposed to report any adverse side effects.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 20 to 50 years old patients with mild to moderate Psoriasis and patients whose bodies were involved below than 20 percent were participated in this study who did not take any medicine to treat psoriasis last three months. Exclusion criteria: Patients with diagnosis of generalized, unstable or pustular Psoriasis who had only skull, nail, flexor surfaces or palms and soles involvement, and patients who were pregnant or breastfeeding, and also patients who were allergic to Plum, Jujube, and Tamarindus indica-derived products were not included in this study.
Intervention groups
Consumer (group) of Florabile syrup
Main outcome variables
The frequency of erythema, plaque, scaling and BSA (Body Surface Area) decreases before and after intervention in patients; The average of PASI (Psoriasiss Area and Severity Index ) decreases before and after intervention in patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200408047000N1
Registration date: 2020-05-04, 1399/02/15
Registration timing: retrospective

Last update: 2020-05-04, 1399/02/15
Update count: 0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Ameneh Parastegari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3324 3522
Email address
mahdavi88311388@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-16, 1397/12/25
Expected recruitment end date
2019-10-30, 1398/08/08
Actual recruitment start date
2019-03-16, 1397/12/25
Actual recruitment end date
2020-03-03, 1398/12/13
Trial completion date
2020-03-18, 1398/12/28
Scientific title
The impact of Florabile syrup on intensity (inflammation, plaque, and scaling) of Psoriasis rashes in patients aged 20 to 50 years.
Public title
The impact of Florabile syrup on intensity of Psoriasis rashes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient must be between 20 to 50 years old. Patients should have mild to moderate Psoriasis and their body should be involved less than 20%. If patient has taken any other drugs to treat Psoriasis, he or she should not consume new dug for three months.
Exclusion criteria:
Patients with generalized, unstable, or pustular Psoriasis who have only skull, nails, flexor surfaces or palms and soles involvement. Patients who are pregnant or breastfeeding. Patients who are allergic to plums, jujube, and Tamarindus indica-derived products.
Age
From 20 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 25
Actual sample size reached: 25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This is a semiexperimental pre and post control study (self-control) which is going to be dine on patients with Psoriasis. The drug under study is available in market and is effective on liver disease treatments; this survey is to study the impact of this syrup on psoriasis. This is a kind of herbal medicine with no known side effects.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-03-13, 1397/12/22
Ethics committee reference number
IR.MUI.MED.REC.1397.344

Health conditions studied

1

Description of health condition studied
Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis

Primary outcomes

1

Description
Suitable (PASI; Psoriasis Area Severity Index) for any patient.
Timepoint
At the beginning of the study (Before intervention) and after finishing the study.
Method of measurement
The software of calculating Psoriasis Severity Area Index. Version 1.7.2

2

Description
Percent of patients body surface involved (BSA; Body Surface Area).
Timepoint
At the beginning of the study (Before intervention) and after finishing the study.
Method of measurement
Calculating formula of the Percent of patients body surface involved.

3

Description
Erythema (redness) of Psoriasis rashes
Timepoint
At the beginning of the study (Before intervention) and after finishing the study.
Method of measurement
Observation.

4

Description
Induration (plaque) of Psoriasis rashes.
Timepoint
At the beginning of the study (Before intervention) and after finishing the study.
Method of measurement
Observation.

5

Description
Desquamation (scaling) of Psoriasis rashes.
Timepoint
At the beginning of the study (Before intervention) and after finishing the study.
Method of measurement
Observation.

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group: Consumer of Florabil syrup consisting:Tamarindus indica, Prune's domestica, Prune's spinosa L, Ziziphus juijub mill, Cordia myxa, Prunus armeniaca, Manna; and the benefits of this syrup includes increasing bile flow and facilitate it to exit the body, cleansing and strengthening the liver, controlling liver heat, removing tongue and skin dryness. No specific side effects have been reported for this medicine. 25patients aged 20 to 50 years with mild to moderate Psoriasis participated the study for a 30 day experimental period; and they diluted Florabile Syrup from Farateb company of Yazd containing three spoons (each spoon with an approximate volume of 15cc) with a glass of water and consumed one hour before lunch daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Persian Medicine Group Center, Amin hospital
Full name of responsible person
Mohammad Mazaheri
Street address
Persian Medicine Group Center, Amin hospital, Ibn Sina Street.
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3447 4246
Email
Mazaherimohammad@med.mui.ac.ir

2

Recruitment center
Name of recruitment center
Skin Diseases and Leishmaniasis Research Center
Full name of responsible person
Ameneh Parastegari
Street address
Skin Diseases and Leishmaniasis Research Center, Sedigheh Tahereh hospital, Khorram Street.
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3337 3736
Email
sdlrc@mui.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoy javanmard
Street address
Research and Technology Branch of University, Building No. 4, Isfahan University of Medical Sciences, Hezarjerib Street.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Ameneh Parastegari
Position
Graduated in general physician
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 79, Kosar Alley, Pasdaran Street,West Baharestan Street, Imam Khomeini Street.
City
Isfahan
Province
Isfehan
Postal code
8195618888
Phone
+98 31 3324 3522
Fax
Email
mahdavi88311388@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Mazaheri
Position
Associate professor, Director of Persian Medicine Group
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Persian Medicine Group, Amin Hospital, Ibn Sina Street.
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3447 4246
Email
Mazaherimohammad@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ameneh Parastegari
Position
Graduated in general physician
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 79, Kosar Alley, Pasdaran St, West Baharestan St, Imam Khomeini St.
City
Isfahan
Province
Isfehan
Postal code
8195618888
Phone
+98 31 3324 3522
Fax
Email
mahdavi88311388@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Parts of data(Information about the consequences) allowed to be shared after making participants unknowable.
When the data will become available and for how long
Access time starts 6 months after printing the results.
To whom data/document is available
Dermatologists and complementary medicine specialist, researchers employed in academic and scientific institutions.
Under which criteria data/document could be used
Only to help patients and for research purposes, any usage with citation.
From where data/document is obtainable
Visiting Iranian Medicine Center at Amin hospital in Isfahan or email to : mahdavi88311388@gmail.com
What processes are involved for a request to access data/document
Email to mahdavi88311388@gmil.com and after sending the email, the data will be sent as soon as possible.
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