The objective of this study is to investigate the therapeutic effect of wet cupping in reduction of liver enzymes and sonography pattern among patients with Non Alcoholic Fatty Liver Disease (NAFLD). Inclusion criteria: all patients with laboratorial and sonographical criteria of fatty liver. Exclusion criteria: patients with viral hepatitis, hemochromatosis, Wilson or autoimmune hepatitis. Sample size: 60 patients in each group. Patients in case group are treated by wet cupping and those who are in control group are treated by conventional methods for NAFLD. Finally patients will be assessed according to reduction in their liver enzymes and improvement in sonography patterns.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905154520N1
Registration date:2010-09-04, 1389/06/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-04, 1389/06/13
Registrant information
Name
Saeed Hamzehi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1723 2429
Email address
shamzehi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2010-07-06, 1389/04/15
Expected recruitment end date
2010-11-06, 1389/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the therapeutic effect of wet cupping among patients with Non Alcoholic Fatty Liver Disease
Public title
Investigating the therapeutic effect of wet cupping among patients with Non Alcoholic Fatty Liver Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with laboratorial and sonographical criteria of fatty liver. Exclusion criteria: patients with viral hepatitis, hemochromatosis, Wilson or autoimmune hepatitis.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
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 Kermanshah University of Medical Sciences
Street address
Shahid-Beheshti Blvd
City
Kermanshah
Postal code
Approval date
2010-07-19, 1389/04/28
Ethics committee reference number
7/420/13943/پ
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
enzymes variation
Timepoint
Before intervention and 14 months after intervention
Method of measurement
Laboratorial criteria
2
Description
liver sonography
Timepoint
Before intervention and 14 months after intervention
Method of measurement
liver sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Wet Cupping
Category
Treatment - Other
2
Description
Control group: diet interpretation and physical exercise
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Bashiri
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Nourizad
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Bashiri
Position
Spesialist in Gastroenterology
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Phone
+98 83 1721 0779
Fax
Email
hbashiri@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Saeed Hamzehi
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences - Imam Reza Hospital – Internal medicine group
City
Kermanshah
Postal code
Phone
+98 83 1723 2429
Fax
Email
shamzehi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Saeed Hamzehi
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences- Imam Reza Hospital – Internal medicine group
City
Kermanshah
Postal code
Phone
+98 83 1723 2429
Fax
Email
shamzehi@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)