Determine the effect of wet cupping therapy on the levels of blood lipids and grade of fatty liver in non-alcoholic patients.
Design
Clinical trials with control group, parallel and randomized groups.
Settings and conduct
Sampling will be done at the internal medicine specialist's office. People, who have the conditions to enter the study, will be sent to conduct liver ultrasound and blood tests.The intervention will be done at the traditional medicine clinic in Mashhad.
Participants/Inclusion and exclusion criteria
Participants will include a number of patients with Non-Alcoholic Fatty Liver Disease referring to an Internal Medicine Specialist in 2018, Which will be selected in terms of entry criteria from the research community.
Intervention groups
Liver ultrasound and blood lipids and liver enzymes test will be performed after 8-12 hours of fasting before and after intervention. In the test group, after disinfection of the site with iodine and clearing with alcohol, the cup will be placed in the area between two scapula and on the third and fourth lumbar vertebrae. Then scratches will be created and the cup will be re-placed. After about one minute and collection 20 cc of blood, the cup will be removed and the place will be dressed. The frequency of treatment with cupping will be two times and every two weeks. All individuals are advised to observe a modified diet and physical activity, according to guidelines published for overweight and obese individuals by the National Institutes of Health and the United States Study of Obesity in North America.
Main outcome variables
Treatment of non-alcoholic fatty liver disease؛ Treatment of high blood lipids؛ Development of Traditional Iranian Medicine,Combining Traditional Medicine with New Therapies, Reduce the cost of treating non-alcoholic fatty liver disease, Development of complementary medicine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180711040437N1
Registration date:2018-08-13, 1397/05/22
Registration timing:prospective
Last update:2018-08-13, 1397/05/22
Update count:0
Registration date
2018-08-13, 1397/05/22
Registrant information
Name
Seyed Hassan Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3272 2547
Email address
ghorbani.h@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of wet cupping therapy on the levels of blood lipids and grade of fatty liver in non-alcoholic patients.
Public title
The effect of wet cupping therapy on the levels of blood lipids and grade of fatty liver in non-alcoholic patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
They do not have hyperlipidemia
They do not drink alcohol
They do not have a history of kidney failure and coronary artery diseases
In the last two months, they do not have wet cupping therapy and blood donation
They do not have a history of severe movement restrictions
Exclusion criteria:
Any treatment or intervention that is carried out during the study and affect the variables of the research.
Changes in the patient's condition so that it is not allowed to continue cupping therapy, such as pregnancy.
Patients' lack of satisfaction to continue their collaboration in the research project.
Age
From 5 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the samples will be selected by targeted sampling from the research community (taking into account entry criteria) and they will be randomly assigned to two groups of control (non-wet cupping) and test (wet cupping) using permutable blocks method.
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 Gonabad University of Medical Sciences
Street address
Asiayi Road Behinde
City
Gonabad
Province
Razavi Khorasan
Postal code
97548-89625
Approval date
2018-07-16, 1397/04/25
Ethics committee reference number
IR.GMU.REC.1397.039
Health conditions studied
1
Description of health condition studied
Non-alcoholic Fatty Liver Disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Cholesterol
Timepoint
Before Intervention, One Month Later of second Wet Cupping Therapy
Method of measurement
Pars Azmoon kit and BT 3000 Device
2
Description
Triglyceride
Timepoint
Before Intervention, One Month Later of second Wet Cupping Therapy
Method of measurement
Pars Azmoon kit and BT 3000 Device
3
Description
Aspartate Aminotransferase Test
Timepoint
Before Intervention, One Month Later of second Wet Cupping Therapy
Method of measurement
Pars Azmoon kit and BT 3000 Device
Secondary outcomes
1
Description
Cholesterol Test
Timepoint
Before Intervention and One month later of Second Wet Cupping Therapy
Method of measurement
Pars Azmoon Kit and BT 3000 Device
2
Description
Triglyceride
Timepoint
Before Intervention and One month later of Second Wet Cupping Therapy
Method of measurement
Pars Azmoon Kit and BT 3000 Device
3
Description
Aspartat Aminotransferase Test
Timepoint
Before Intervention and One month later of Second Wet Cupping Therapy
Method of measurement
Pars Azmoon Kit and BT 3000 Device
Intervention groups
1
Description
Intervention group: Two times wet cupping therapy every two weeks and dietary recommendations of the Association of Obesity.
Category
Treatment - Other
2
Description
Control group: Only dietary recommendations of the association of obesity of north america
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
مطب متخصص داخلی
Full name of responsible person
سید حسن قربانی
Street address
No 3, Negin Building, Khayyam Street, sajjad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
97751-89367
Phone
+98 51 3760 3458
Email
ghorbani.h@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Seyed Hasan Ghorbani
Street address
Assiayi Road Behind
City
Gonabad
Province
Razavi Khorasan
Postal code
97352-86457
Phone
+98 51 5722 3028
Email
ghorbani.h@gmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Nursing College
Proportion provided by this source
1
Public or private sector
Private
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
Gonabad University of Medical Sciences
Full name of responsible person
Seyed Hasan Ghorbani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Asiayi Road Behind
City
Gonabad
Province
Razavi Khorasan
Postal code
97568-85364
Phone
+98 51 5722 3028
Email
ghorbani.h@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Seyed Hasan Ghorbani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Asiayi Road Behind
City
Gonabad
Province
Razavi Khorasan
Postal code
97584-89654
Phone
+98 51 5722 3028
Email
ghorbani.h@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Seyed Hassan Ghorbani
Position
Nursing student in master
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
39 ,besat 7 , north besat street
City
Ferdows
Province
South Khorasan
Postal code
97751-89367
Phone
+98 56 3272 2547
Fax
Email
ghorbani.h@gmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No More Information.
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only the method of work and the results of the intervention will be shared.
When the data will become available and for how long
23/06/2019
To whom data/document is available
Total Researcher
Under which criteria data/document could be used
Specimen data will not be sent.
From where data/document is obtainable
Iran, Razavi Khorasan, Gonabad, Gonabad University of Medical Science
What processes are involved for a request to access data/document