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Effectiveness of wet cupping on moderate and severe acne in patients under treatment with Azithromycin

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History
# Registration date Revision Id
3 2020-07-19, 1399/04/29 143935
2 2020-02-14, 1398/11/25 124273
1 2018-08-05, 1397/05/14 55325
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  • Protocol summary

    A randomized, blinded, controlled clinical trial with a parallel group design of 108 patients, enrolled from 6 August 2018 , and followed for 3 months. Randomization is done with coin.
    A randomized, blinded, controlled clinical trial with a parallel group design of 108 patients, enrolled from 6 August 2018 , and followed for 3 months. Randomization is done via "Blocked Randomization List".
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سویه کور، تصادفی شده که شامل 108 بیمار می باشد که بیمار گیری از 15 مرداد ماه 1397شروع شده و بیماران تا سه ماه پیگیری می شوند. تصادفی سازی باپرتاب سکه انجام می شود.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سویه کور، تصادفی شده که شامل 108 بیمار می باشد که بیمار گیری از 15 مرداد ماه 1397شروع شده و بیماران تا سه ماه پیگیری می شوند. تصادفی سازی از طریق "Blocked Randomization List" انجام می شود.
    The study is conducted at the Dermatology Clinic of the Faghih Hospital. For each patient, a coin is thrown once and in the case of a lion, the patient will be placed in the intervention group and in the case of a line, the patient will be placed in the control group. All participants receive classical medicine, but in the intervention group, wet cupping is done, in addition to the classic treatment, the dermatologist and the person analyzing the information are unaware of the cupping.
    The study is performed in the dermatology clinic of Shahid Faghihi Hospital. In this study, patients with mild to moderate acne between the ages of 18-35 years are randomly divided into intervention and control groups through the "Blocked Randomization List". All participants receive classical medicine, but in the intervention group, in addition to classical treatment, cupping is performed. The dermatologist and the person analyzing the information are unaware of the cupping.
    مطالعه در درمانگاه پوست بیمارستان شهید فقیهی انجام می شود. برای هر بیمار یکبار سکه پرتاب می شود و در صورت شیر امدن بیمار را در گروه مداخله ودر صورت خط امدن بیمار را در گروه شاهد قرار خواهیم داد. تمامی شرکت کنندگان داروی کلاسیک دریافت می کنند ولی در گروه مداخله علاوه بر درمان کلاسیک حجامت انجام می شود.متخصص پوست بررسی کننده و فرد انالیز کننده اطلاعات نسبت به انجام حجامت بی اطلاع هستند.
    مطالعه در درمانگاه پوست بیمارستان شهید فقیهی انجام می شود. در این مطالعه بیماران با بیماری اکنه خفیف تا متوسط با سن بین 35-18 سال بصورت تصادفی از طریق "Blocked Randomization List" به دو گروه مداخله و کنترل تقسیم می شوند. تمامی شرکت کنندگان داروی کلاسیک دریافت می کنند ولی در گروه مداخله علاوه بر درمان کلاسیک حجامت انجام می شود. متخصص پوست بررسی کننده و فرد انالیز کننده اطلاعات نسبت به انجام حجامت بی اطلاع هستند.

  • General information

    Due to the lack of erythromycin antibiotics in the market, azithromycin antibiotics were used and some minor changes were made.
    At the discretion of the research group, instead of randomization through coins, the Internet randomization "Blocked Randomization List" was used, and unfortunately, the registration of this change in "IRCT" has been forgotten.
    با توجه به عدم وجود انتی بیوتیک اریترومایسین در بازار از انتی بیوتیک ازیترومایسین استفاده شد و یکسری تغییرات جزئی صورت گرفت.
    با صلاحدید گروه پژوهشی به جای تصادفی سازی از طریق سکه از تصادفی سازی اینترنتی "Blocked Randomization List" استفاده شد و متاسفانه ثبت تغییر این اصلاح در "IRCT" فراموش شده است.
    For each patient, a coin is thrown once and in the case of a lion, the patient will be placed in the intervention group and in the case of a line, the patient will be placed in the control group.
    At first, according to the inclusion criteria, patients are selected and then according to the random sequence obtained through the "Blocked Randomization List" (random blocking with 6 blocks), in the same random order, patients will be divided into intervention and control groups.
    برای هر بیمار یکبار سکه پرتاب می شود و در صورت شیر امدن بیمار را در گروه مداخله ودر صورت خط امدن بیمار را در گروه شاهد قرار خواهیم داد.
    در ابتدا با توجه به معیارهای ورود به مطالعه، بیماران انتخاب می شوند و سپس با توجه به توالی تصادفی به دست آمده از طریق "Blocked Randomization List" (بلوک بندی تصادفی با بلوک های 6 تایی)، به همان ترتیب تصادفی، بیماران در دو گروه مداخله و کنترل قرار خواهند گرفت.

Protocol summary

Study aim
Determine the effect of wet cupping on moderate and severe acne
Design
A randomized, blinded, controlled clinical trial with a parallel group design of 108 patients, enrolled from 6 August 2018 , and followed for 3 months. Randomization is done via "Blocked Randomization List".
Settings and conduct
The study is performed in the dermatology clinic of Shahid Faghihi Hospital. In this study, patients with mild to moderate acne between the ages of 18-35 years are randomly divided into intervention and control groups through the "Blocked Randomization List". All participants receive classical medicine, but in the intervention group, in addition to classical treatment, cupping is performed. The dermatologist and the person analyzing the information are unaware of the cupping.
Participants/Inclusion and exclusion criteria
Criteria for entering the plan: Includes severe and moderate acne on the face, and informed consent to participate in the study and non- pregnancy and no specific disease including hormonal imbalance, chronic diseases, anemia, other coagulation problems and other infectious diseases. Exit criteria: Includes pregnancy and the emergence of specific illness during treatment, as well as cupping in the past three months and taking roaccutane over the past year.
Intervention groups
In this survey, the studied population is between the ages of 18-35 with moderate or severe acne. Participants are randomly divided into two groups. All participants (intervention group and control group) receive oral antibiotics based on the standard treatment protocol. In the intervention group, wet cupping is done twice, with 6 weeks interval (once at the beginning and second time 6 weeks later).
Main outcome variables
Severity of Acne

General information

Reason for update
At the discretion of the research group, instead of randomization through coins, the Internet randomization "Blocked Randomization List" was used, and unfortunately, the registration of this change in "IRCT" has been forgotten.
Acronym
IRCT registration information
IRCT registration number: IRCT20180623040199N1
Registration date: 2018-08-05, 1397/05/14
Registration timing: prospective

Last update: 2020-07-21, 1399/04/31
Update count: 2
Registration date
2018-08-05, 1397/05/14
Registrant information
Name
Fatemeh Tabatabaeishourijeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3312 2912
Email address
f.tabatabaei@Kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2019-01-05, 1397/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of wet cupping on moderate and severe acne in patients under treatment with Azithromycin
Public title
Effectiveness of wet cupping on moderate and severe acne in patients under treatment with Azithromycin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate and severe acne on the face; Informed consent to participate in the study; No pregnancy; Without any specific disease including chronic diseases, hormonal imbalance, anemia, and other coagulation problems, and Aids and other infectious diseases.
Exclusion criteria:
Pregnancy; Occurrence of specific diseases during treatment; Wet cupping in the past three months; Taking roaccutane in the past year.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
At first, according to the inclusion criteria, patients are selected and then according to the random sequence obtained through the "Blocked Randomization List" (random blocking with 6 blocks), in the same random order, patients will be divided into intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
A dermatologist who checks patients at intervals is unaware of the wet cupping. The analyzer is unaware of the patients whom wet cupping is done for them.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Thirteenth floor, block A, Central Headquarters of the Ministry of Health and Medical Education, simaye Iran Street between South Felamak and Zarafshan, Ghods Town (West), Tehran.
City
Tehran
Province
Tehran
Postal code
1936773493
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
IR.KMU.REC.1397.096

Health conditions studied

1

Description of health condition studied
Acne
ICD-10 code
L70.0
ICD-10 code description
Xii Diseases of skin and subcutaneous tissues

Primary outcomes

1

Description
Acne
Timepoint
Initially, the sixth week and the twelfth week
Method of measurement
By using Modified Global Acne Grading Score

Secondary outcomes

1

Description
Quality of Life
Timepoint
Initially and the twelfth week
Method of measurement
Questionnaire

2

Description
The prevalent temperament of people with acne
Timepoint
Initially and the twelfth week
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: In the back area between the first to third thoracic vertebra, during the first visit and the sixth week, the cupping will be done. In addition, antibiotic antibiotic azithromycin will be given 3 times a week.
Category
Treatment - Other

2

Description
Control group:They will receive antibiotic azithromycin three times a week, as well as sham cupping.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology Clinic of the Martyr Faghih Hospital
Full name of responsible person
Mohammam Mahdi Parvizi
Street address
Faghih Hospital, Zand St, Shiraz.
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۴۱۱۹
Phone
+98 71 3235 2220
Fax
+98 71 3233 1634
Email
MMParvizi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Haleh Tajadini
Street address
College of Iranian Medicine, Pardis,Corner of Sajjadiyeh St. ,Modiriat St.,Kerman
City
Kerman
Province
Kerman
Postal code
7615687644
Phone
+98 34 3312 2912
Fax
+98 34 3312 2023
Email
Dr-Haleh@yahoo.com
Grant name
124701
Grant code / Reference number
1603003000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Tabatabaeishourijeh
Position
Traditional Medicine student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
College of Iranian Medicine, pardis,Corner of Sajjadiyeh St. ,Modiriat St.,Kermaniriat St.,Kerman
City
Kerman
Province
Kerman
Postal code
7615687644
Phone
+98 34 3312 2912
Fax
+98 34 3312 2023
Email
shahrzad.tab7@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Haleh Tajadini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
College of Iranian Medicine, pardis,Corner of Sajjadiyeh St. ,Modiriat St.,Kermanh,Modiriat St.,Kerman
City
Kerman
Province
Kerman
Postal code
7615687644
Phone
+98 34 3312 2912
Fax
+98 34 3312 2023
Email
Dr-haleh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Tabatabaeishourijeh
Position
Ph.D. student of traditional medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
College of Iranian Medicine, pardis,Corner of Sajjadiyeh St. ,Modiriat St.,Kerman
City
Kerman
Province
Kerman
Postal code
7615687644
Phone
+98 34 3312 2912
Fax
+98 34 3312 2023
Email
Shahrzad.tab7@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
It is published through the supplementary file
When the data will become available and for how long
6 months
To whom data/document is available
Researchers and other people can access data if they need it
Under which criteria data/document could be used
For using in systematic review articles, reprogramming and modeling can be used in other studies. In case of need, should be emailed to the programmer or entered university site.
From where data/document is obtainable
Executor of plan or University
What processes are involved for a request to access data/document
Email the scheduler,she answers.
Comments
All information is available to others for the advancement of science.
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