Investigating the effect of wet cupping therapy on general health, blood cell count and expression of transcription factors genes T lymphocyte subsets in healthy men
Evaluation of the effect of wet cupping on health, hematologic parameters, and immune system
Design
The study will be conducted on healthy men between 20 and 40 years old. The samples will be divided into two groups of wet cupping and cupping by simple randomization. The blood sample will be taken before the intervention and 1 week and 1 month after the intervention. The gene expression of lymphocytes T will be measured. The sample size is measured by previous studies on gene expression. After the initial interview and obtaining consent form and random sampling, interventions will be conducted in sterile conditions
Settings and conduct
Clinic of Faculty of Traditional Medicine and Supplement-Mashhad University of Medical Sciences,
Participants/Inclusion and exclusion criteria
Inclusion criteria 1-Demographic criteriaHealthy men age range 25 to 40Weight above 50 kilograms and BMI up to 30 2-Common health test score under 60 3-Biologic and clinical criteriaBlood Hemoglobin minimum 12.5 gram per deciliter and 38% hematocritOral temperature up to 37.5 centigrade degreeBlood pressure: systolic blood pressure between 100 to 140 mm Hg and diastolic blood pressure between 70 to 100 mm Hg is acceptable 4-Without confirmed background of chronic diseases
Exclusion criteria
1.Infected with the acute infectious disease during the study
2. No completion of the study by the participant
Intervention groups
In the intervention group, the area between the shoulders first anointment, and then the wet cupping is done.
In the control group, the shoulder area only anoint
Main outcome variables
Health level-CBC-Expression of transcription factors genes of T lymphocyte subsets
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170806035515N2
Registration date:2018-09-01, 1397/06/10
Registration timing:retrospective
Last update:2018-09-01, 1397/06/10
Update count:0
Registration date
2018-09-01, 1397/06/10
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3609 9364
Email address
soleimanir911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-11-21, 1396/08/30
Actual recruitment end date
2018-03-19, 1396/12/28
Trial completion date
empty
Scientific title
Investigating the effect of wet cupping therapy on general health, blood cell count and expression of transcription factors genes T lymphocyte subsets in healthy men
Public title
The effect of cupping on health, blood and immune system
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy men aged 25 to 40 years old
Weight over 50 kg and BMI below 30
The general health questionnaire score is below 60
Hemoglobin levels are higher than 12.5 g / dl and the hematocrit is more than 38%.
Oral temperature is less than 37.5 ° C.
Systolic blood pressure between 100-140 mm Hg and Diastolic blood pressure is between 100-70 mm Hg are acceptable.
There is no confirmed history of chronic diseases
Exclusion criteria:
Infected with acute infectious disease including common colds and ... during the study
Contributor does not cooperate until the end of the study
Age
From 20 years old to 40 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization between two groups is simple and using a random number table by computer
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Thai Clinical Trials Registry
Secondary trial Id
TCTR20160609004
Registration date
2016-08-26, 1395/06/05
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellery for Research of Mashhad University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Approval date
2016-04-30, 1395/02/11
Ethics committee reference number
IR.MUMS.REC.1395.44
Health conditions studied
1
Description of health condition studied
health
ICD-10 code
ICD-10 code description
2
Description of health condition studied
blood parameters
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Immune System
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
health level
Timepoint
Before intervention-One week after the intervention-4 weeks after intervention
Method of measurement
General Health Questionnaire 28 questions(GHQ-28)
2
Description
Gene expression of GATA-3 transcription factors
Timepoint
Before intervention-One week after the intervention- 4 weeks after intervention
Method of measurement
Real time-PCR
3
Description
CBC parameters
Timepoint
Before intervention-One week after the intervention-4 weeks after intervention
Method of measurement
By cell counting machine
4
Description
Gene expression of T-bet transcription factor
Timepoint
Before intervention-One week after the intervention-4 weeks after intervention
Method of measurement
Real time-PCR
5
Description
Gene expression of RORɣt transcription factor
Timepoint
Before intervention-One week after the intervention-4 weeks after intervention
Method of measurement
Real time-PCR
6
Description
Gene expression of Foxp-3 transcription factor
Timepoint
Before intervention-One week after the intervention-4 weeks after intervention
Method of measurement
Real time-PCR
7
Description
Gene expression of GATA-3 transcription factor
Timepoint
Before intervention-One week after the intervention-4 weeks after intervention
Method of measurement
Real time-PCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:wet cupping between two shoulders
Category
Treatment - Other
2
Description
Control group: anoint between two shoulders
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Traditional Medicine and Supplement
Full name of responsible person
Dr. Reza soleimani
Street address
Emamreza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۸۵۷۹۹۹۵۵
Phone
+98 51 3609 9364
Email
soleimanir911@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research,Mashhad University of Medical
Full name of responsible person
Dr. Mohsen Tafaghodi, Research Vice Chancellor
Street address
Vice Chancellery for Research of Mashhad University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91375345
Phone
+98 51 3841 1538
Email
Vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research,Mashhad University of Medical
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
Mashhad University of Medical Sciences, Faculty of Traditional Medicine and Supplement Mashhad
Full name of responsible person
Rezasoleimani
Position
Phd student of Traditional Iranian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Azadi Square, Ferdowsi University, Pardis, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9179155453
Phone
+98 51 3609 9364
Fax
Email
soleimanir911@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical
Full name of responsible person
Dr. Jalil Tavakoli Afshar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Vice Chancellery for Research of Mashhad University of Mashhad
City
Mashhed
Province
Razavi Khorasan
Postal code
91375345
Phone
+98 51 3609 9364
Fax
Email
Tavakolaj@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical
Full name of responsible person
Dr.Reza soleimani
Position
Phd Studentof Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Azadi Square, Ferdowsi University, Pardis, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۸۵۷۹۹۸۸۸
Phone
+98 51 3609 9364
Fax
Email
soleimanir911@mums.ac.ir
Web page address
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
Changes in health, blood parameters, and gene expression
When the data will become available and for how long
After publishing the article in the journal
To whom data/document is available
Everyone
Under which criteria data/document could be used
In studies on complementary medicine
From where data/document is obtainable
to the master of the project
What processes are involved for a request to access data/document
An email will be sent to the master responsible for the project, with personal details and academic status and ongoing study