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Comparison of the simultaneous effect of all three therapeutic methods of Fire needle, Moxibustion, and auriculotherapy with and without light therapy with narrow band ultraviolet rays (NB-UVB) in vitiligo patients

Protocol summary

Study aim
Comparison of therapeutic effect of warm acupuncture, massage and auriculotherapy with and without light therapy in vitiligo patients
Design
The trial has two groups of 5 people, including the first group (control group), treatment without light therapy, treatment with warm acupuncture, massage and auriculotherapy, and the second group, in addition to light therapy, treatment with warm acupuncture, massage and auriculotherapy, and statistical methods used to compare groups in terms of primary and secondary outcomes, methods used in additional analyses, such as subgroup analyzes and adjusted analyses.)
Settings and conduct
This study was conducted at the Molecular Dermatology Research Center affiliated to Shiraz University of Medical Sciences and the Dermatology Clinic of Faqihi Hospital in Shiraz and as an experiment in the form of a single-blind randomized controlled clinical trial, which was randomized based on the permutation table. The treatments were given twice in The week is done for three months and the patients are followed up for 6 months.
Participants/Inclusion and exclusion criteria
Patients, regardless of ethnicity and disease duration, at least 18 years old and without serious systemic disease, will participate in this study after a doctor's visit, eligibility and signed consent form. Pregnant and lactating mothers and special patients will not participate in this study.
Intervention groups
Treatment with hot acupuncture, massage and auriculotherapy with and without light therapy
Main outcome variables
The recovery rate of lesions of vitiligo patients The percentage of vitiligo involvement is calculated per hand unit.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110731007160N9
Registration date: 2023-08-07, 1402/05/16
Registration timing: prospective

Last update: 2023-08-07, 1402/05/16
Update count: 0
Registration date
2023-08-07, 1402/05/16
Registrant information
Name
Nasrin Hamidizadeh
Name of organization / entity
Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
hamidizade@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-11, 1402/05/20
Expected recruitment end date
2023-10-21, 1402/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the simultaneous effect of all three therapeutic methods of Fire needle, Moxibustion, and auriculotherapy with and without light therapy with narrow band ultraviolet rays (NB-UVB) in vitiligo patients
Public title
Comparison of the therapeutic effect of fire-needling, moxibustion and auriculotherapy in vitiligo patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Regardless of ethnicity and disease duration, patients at least 18 years of age and without severe systemic disease will participate in this study after a physician visit, eligibility, and signing of an informed consent form.
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-01-10, 1401/10/20
Ethics committee reference number
IR.SUMS.REC.1401.641

Health conditions studied

1

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

Primary outcomes

1

Description
Pigmentation in vitiligo lesions
Timepoint
Pigmentation in vitiligo lesions
Method of measurement
Vitiligo Area Scoring Index (VASI)

Secondary outcomes

1

Description
Intervention group: Patients are divided into two groups of 5 people who will participate in each group. In addition to light therapy, the intervention group is also treated with hot acupuncture, massage and auriculotherapy.
Timepoint
Treatment will be given twice a week for three months, and patients will be followed up for six months.
Method of measurement
Vitiligo Area Scoring Index (VASI)

Intervention groups

1

Description
Intervention group: Patients are divided into two groups of 5 people. In the first intervention group, in addition to light therapy, treatment with hot acupuncture, massage, and auriculotherapy is also performed.
Category
Treatment - Other

2

Description
Intervention group: Patients are divided into two groups of 5 people. The second intervention group without light therapy, the treatment is done only with the help of hot acupuncture, massage and auriculotherapy.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Molecular Dermatology Research Center
Full name of responsible person
Dr.Nasrin Hamidizadeh
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
n.hamidizadeh.mdrc@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
7th Floor, Administration Building of Shiraz University of Medical Sciences, Office of the Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences, Zand Ave., Shiraz, IRAN
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Nasrin Hamidizadeh
Position
Manager of Research Center
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
hamidizade@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Nasrin Hamidizadeh
Position
Director
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
n.hamidizadeh.mdrc@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Ranjbar
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Others
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
s.ranjbar.mdrc@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
Presenting the results of the VASI index regarding the percentage of improvement
When the data will become available and for how long
Immediately after the publication of the article
To whom data/document is available
Researchers
Under which criteria data/document could be used
Send researchers' requests via email and make a commitment to applicants to protect the data
From where data/document is obtainable
Sending researchers' requests via e-mail to the e-mail address of the executor and in charge of the project, Dr. Nasrin Hamidizadeh. n.hamidizadeh.mdrc@gmail.com
What processes are involved for a request to access data/document
The applicant researcher should send his request to the email address of the executor of the project, Dr. Nasrin Hamidizadeh (n.hamidizadeh.mdrc@gmail.com). Within one week after evaluation, the data will be sent to the applicant via email, along with making a commitment.
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