Protocol summary

Study aim
Evaluation of the effect of Atrilal plant on vitiligo
Design
Clinical trial with intervention and control groups, with parallel groups, double-blind, randomized, phase 3 on 62 patients. A random table was used for randomization.
Settings and conduct
This study will be performed as a clinical trial for patients with vitiligo referred to Omid Clinic and Farshchian Hospital in the dermatology ward in 1999. The daily requirement of each person according to the sources of Iranian medicine is two ounces (each ounce is equal to 4.608 grams) of Falcaria Vulgaris egg with the same weight as honey, which should be used for 15-20 days. The same amount of starch and honey will be prepared in containers that look exactly like medicine containers without a label identifying the drug or placebo. Both groups will receive BLIND for 20 days. After one week and after the end of the treatment period, the patients will be examined by a dermatologist and Iranian medicine. Patients will be re-examined one month after the end of the treatment period.
Participants/Inclusion and exclusion criteria
Clinical diagnosis of vitiligo recently or in case of previous diagnosis of non-drug use from one month ago, normal blood, liver, kidney, anti-nuclear antibodies and eye examination, no use of effective concomitant treatment for vitiligo, no pregnancy, no Having light-sensitive diseases such as lupus and porphyria, not using light-sensitizing drugs such as retinoids and cotrimoxazole
Intervention groups
Each person is given two ounces (4.608 grams per ounce) of Falcaria Vulgaris egg with the same weight of honey daily to be used for 15-20 days. The same amount of starch and honey will be prepared in containers that look exactly like medicine containers without a label identifying the drug or placebo.
Main outcome variables
Lack of response to treatment, partial recovery, complete recovery in all lesions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160627028664N3
Registration date: 2020-10-05, 1399/07/14
Registration timing: prospective

Last update: 2020-10-05, 1399/07/14
Update count: 0
Registration date
2020-10-05, 1399/07/14
Registrant information
Name
Azam Meyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0572
Email address
ameyari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2020-11-06, 1399/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of Falcaria vulgaris on vitiligo
Public title
Investigation the effect of Falcaria vulgaris on vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of vitiligo recently or in case of previous diagnosis of non-drug use from one month ago Normal blood, liver, kidney, anti-nuclear antibody (ANA) tests and eye examination
Exclusion criteria:
Use of effective concomitant treatment in vitiligo Pregnancy Personal or family history of light-sensitive Suffering from light-sensitive diseases such as lupus and porphyria Use of light-sensitizing drugs such as retinoids and cotrimoxazole
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, we will use the BalancedBlock Randomization method (block size=4). Random allocation software will be used for this purpose. At first, we prepare two sheets of paper. We write "Intervention" on a paper and "Standard treatment" on another. Mix the sheets together and place them on the desk drawer. With the referral of each of the eligible patients, one of the cards will be drawn randomly and based on this drawn card, it will be assigned to one of the two groups. It should be noted that the drawn sheets will not be returned to the drawer until all four sheets have been removed. After all four sheets are drawn randomly, all the sheets are returned to the drawer and the above operation will be continued for the next four patients until the desired sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient and the researcher and those who prepare the medicine and the person who gives the medicine to the patient and the doctor who performs the tests and examinations are unaware of the allocation of study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
15th floor, Block a, Sepid Tower, Maskin Alley, Besat Boulevard
City
Hamadan
Province
Hamadan
Postal code
6516938864
Approval date
2020-09-20, 1399/06/30
Ethics committee reference number
IR.UMSHA.REC.1399.547

Health conditions studied

1

Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo

Primary outcomes

1

Description
Size of skin lesions
Timepoint
At the beginning of the study, after 20 days, after a month, after two months
Method of measurement
Based on standard grading VASI and VIDA

2

Description
color of skin lesions
Timepoint
At the beginning of the study, after 20 days, after a month, after two months
Method of measurement
Based on standard grading VASI and VIDA

3

Description
Follicular pigmentation
Timepoint
At the beginning of the study, after 20 days, after a month, after two months
Method of measurement
Based on standard grading VASI and VIDA

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, first the seeds of Atrilal plant are prepared and after identifying and confirming the scientific name in the pharmacognosy group of Hamadan School of Pharmacy, they are washed and dried thoroughly. Three hundred grams of the plant will be essential oil extracted using a water distillation method using a Clevenger device. To identify the components, the essential oil will be injected into a gas chromatographic apparatus. Essential oil components will be identified according to their inhibition time and related calculations. It is identified and after performing microbial laboratory tests, etc. by the herbarium laboratory, it is ground and mixed with honey in equal amounts. The daily requirement of each person according to the sources of Iranian medicine is two ounces (each ounce equal to 4.608 grams) of Falcaria Vulgaris egg with the same weight as honey, which should be used for 15-20 days.
Category
Treatment - Drugs

2

Description
The placebo control group is two ounces (each ounce equal to 4.608 grams) of starch with the same weight as honey, which should be prepared in containers very similar to the medicine containers without the label identifying the drug or placebo and used for 15-20 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian (Sina) Hospital
Full name of responsible person
Pedram Alirezaei
Street address
Mirzadeh Eshqi St, Hamedan, Hamadan Province,
City
hamadan
Province
Hamadan
Postal code
65168 48741
Phone
+98 81 3827 4191
Email
razienorouzi78@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azam Meyari
Street address
building number one, at the beginning of Ayatollah Kashani Boulevard, Shariati crossroads
City
Hamadan
Province
Hamadan
Postal code
6517619657
Phone
+98 81 3252 0182
Email
d_a_meyari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Azam Meyari
Position
Ph.D student of Traditional Medicine
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Education and development of medical sciences center, Hamedan University of Medical Sciences, Shahid Fahmideh Ave, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0238
Fax
+98 81 3838 0246
Email
d_a_meyari@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azam Meyari
Position
Ph.D student of Traditional Medicine
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Education and development of medical sciences center, Hamedan University of Medical Sciences, Shahid Fahmideh Ave, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0238
Fax
+98 81 3838 0246
Email
d_a_meyari@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Razie Norouzi
Position
Studend
Latest degree
Bachelor
Other areas of specialty/work
Library and Medical Information
Street address
15th floor, Block A of Sepid tower, Meskin alley , Bessat Blv.
City
Hamadan
Province
Hamadan
Postal code
6516938864
Phone
+98 81 3832 0645
Email
Razienorouzi78@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
After the study, the results and data related to the results of drug use and changes in participants will be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Faculty members, specialists, researchers and students
Under which criteria data/document could be used
For the use of other researchers and those who intend to conduct research on vitiligo and atrial fibrillation.
From where data/document is obtainable
Razie Norouzi razienorouzi78@gmail.com Azam Meyari d_a_meyari@yahoo.com
What processes are involved for a request to access data/document
The applicant must send an e-mail to each of the mentioned persons and submit his / her application and introduce himself / herself, and then the required documents will be emailed to him / her during the analysis performed on the person's resume.
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