Background: Wet cupping therapy has been used in Iran and many ancient societies for thousands of years for discharging dirty blood, but there are few systematic studies and clinical research in this field. The purpose of this study is to compare venous blood with cupping blood and evaluate the effect of cupping on venous blood.
Materials and methods: 20 healthy volunteers who come to traditional medicine clinic for annual routine cupping, are entered the study ( The study is self control and every person is a control for him self, cupping blood sample is case and venous blood before cupping in every person is control for himself). Chronic disease patients and patients under medication are excluded. Intervention is wet cupping on the area between two scapula. After disinfecting the area, the cup is connected to a vacuum apparatus and is placed to the area for 3-4 minutes. The cup is removed and the area is scratched using sterile scalpel. The area is suctioned again and the blood collected in the cup is used for biochemical and metabonomics study. The metabolites of the wet cupping blood and venous blood before cupping and 2 weeks later are compared using metabonomics technique. Blood serum is collected for Metabonomics and biochemical analysis. Metobonomics is a new, high throughput technology which can evaluate more than 5000 metabolites in the body fluids.
Intervention is cupping and variables are biochemical parameters and metabolite of venous blood before cupping, cupping blood and venous blood 2 weeks after cupping.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121620329N1
Registration date:2015-08-26, 1394/06/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-26, 1394/06/04
Registrant information
Name
Zahra Zamani
Name of organization / entity
Pasteur Institute of Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6640 2770
Email address
zamani@pasteur.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2015-05-01, 1394/02/11
Expected recruitment end date
2016-01-01, 1394/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Metabonomics Study of the Effect of Wet Cupping on Blood Components of Healthy Volunteers
Public title
Effect of Wet Cupping on Blood Components of Healthy volunteers
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Healthy male 20-70 years old volunteers, who come to traditional medicine clinic for routine annual wet cupping.
Exclusion criteria: Chronic disease patients and patients under medication
Age
From 20 years old to 70 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Venous blood before cupping, cupping blood and venous blood 2 weeks after cupping in healthy volunteers were analyzed by auto analyzer and 1HNMR. Using modelling software like MATLAB differentiating metabolites between these three samples were detected and identified and the difference in the metabolic cycles between these three were also analyzed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Human Research Ethics Committee of Pasteur Institute of Iran
Street address
12th. St., the eastern Pasteur Ave., Pasteur Sq.,Valiasr Ave. Pasteur institute of Iran
City
Tehran
Postal code
1316943551
Approval date
2012-03-25, 1391/01/06
Ethics committee reference number
P/24/M/T/940
Health conditions studied
1
Description of health condition studied
Healthy condition
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Metobonomics of venous blood and cupping blood
Timepoint
On the same day before and after cupping, 2 weeks later
Method of measurement
Using 1H Nuclear Magnetic Resonance by NMR apparatus
Secondary outcomes
1
Description
triglyceride
Timepoint
On the same day between venous blood and cupping blood , 2 weeks later between first and second venous blood
Method of measurement
With the use of biochemical kits (Pars Azmoon) and autoanalyzer RA 1000
2
Description
High density lipoprotein (HDL)
Timepoint
On the same day before and after cupping, 2 weeks later
Method of measurement
Using biochemical kits (Pars Azmoon) and autoanalyzer RA 1000
3
Description
Low density lipo proteins (LDL)
Timepoint
On the same day before and after cupping, 2 weeks later
Method of measurement
Using biochemical kits(Pars Azmoon) and autoanalyzer RA 1000
4
Description
uric acid
Timepoint
On the same day before and after cupping, 2 weeks later
Method of measurement
Using biochemical kits (Pars Azmoon) and autoanalyzer RA 1000
5
Description
Liver enzymes
Timepoint
On the same day before and after cupping, 2 weeks later
Method of measurement
Using biochemical kits (Pars Azmoon) and autoanalyzer RA 1000
Intervention groups
1
Description
Intervention : Wet cupping using scalpel and suction on a region between the scapula
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Maad Traditional Medicine Center
Full name of responsible person
Dr. Mahdi Fahimi
Street address
1st floor, #1367, Kargar Ave.,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr. Mahdi Fahimi
Street address
no: 1367, Karegar St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Pasteur Institute of Iran Vice chancellor for research
Full name of responsible person
Dr.saeed Bouzari
Position
Associate Professor
Other areas of specialty/work
Street address
no: 1996, Pasteur Ave. Pasteur Sq.
City
Tehran
Postal code
1316943551
Phone
+98 21 6640 2770
Fax
+98 21 6640 2770
Email
bouzari@pasteur.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pasteur Institute of Iran
Full name of responsible person
Dr. Zahra Zamani
Position
Associate Professor
Other areas of specialty/work
Street address
Pasteur Ave.
City
Tehran
Postal code
1316943551
Phone
+98 21 6640 2770
Fax
+98 21 6649 2779
Email
zamani@pasteur.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pasteur Institute of Iran
Full name of responsible person
Dr.Zahra Zamani
Position
Associate Professor
Other areas of specialty/work
Street address
Pasteur Institute of Iran
City
Pasteur Ave.,
Postal code
1316943551
Phone
+98 21 6640 2770
Fax
+98 21 6640 2770
Email
zamani@pasteur.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)