Assessment of pentoxifillin effects on the serum level of inflammatory cytokines(IL-6, IL-8, TNF-α) and liver transaminases in patient with non alcoholic steatohepatitis
The triple-blind study in 30 patients with non alcoholic steatohepatitis in gastroenterology clinics office and hospitals in Kerman AfzaliPour referred projects will be selected. They are listed according to the criteria of the study and were randomly divided into experimental and control groups. Clinical trial of pentoxifylline in NASH through the effect of inflammatory cytokines such as IL_6, IL-8 and TNF-α in Kerman will be studied. The intervention group had a tablet of pentoxifylline (400 mg) and the control group received a placebo three times a day for six months will be prescribed. At the time before, three months and six months later, the IL8, IL6, TNF-α and liver enzymes AST and ALT and BMI were measured. Finally all the collected data was analyzed using SPSS-18 and descriptive statistical tests will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015033021565N1
Registration date:2015-05-19, 1394/02/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-19, 1394/02/29
Registrant information
Name
Nadieh Baniasadi
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 3243 7654
Email address
baniasadi.n@gmail.com
Recruitment status
Recruitment complete
Funding source
kerman University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of pentoxifillin effects on the serum level of inflammatory cytokines(IL-6, IL-8, TNF-α) and liver transaminases in patient with non alcoholic steatohepatitis
Public title
Pentoxifylline effects on the treatment of non alcoholic steatohepatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of non alcoholic steatohepatitis is with clinical and paraclinical criteria (elevated ALT and AST to 1.5 times more than normal and sonography confirmation of fatty liver). Exclusion criteria: Diabetes mellitus; hyperlypidemia; liver diseases(Serum level, ASMA, ANA, FERRITIN, a-1anti tripsin, people with positive markers hepaptitis B virus, hepatitis c & hepatitis a); drug users (Calsium channel blocker, B blocker, amiodarone, glucocorticoids, strogen,...); alcoholic users; people who intervened before and during acute or chronic liveror systemic disease.
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Ibn Sina street - Samia Crossroads -kerman
City
kerman
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
k/91/331
Health conditions studied
1
Description of health condition studied
non alcoholic steatohepatitis
ICD-10 code
k76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
ALT
Timepoint
Before the intervention, third month after intervention, sixth mounth after intervention
Method of measurement
Blood Exam
2
Description
AST
Timepoint
Before the intervention, third month after intervention, sixth mounth after intervention
Method of measurement
Blood Exam
3
Description
BMI
Timepoint
Before the intervention, third month after intervention, sixth mounth after intervention
Method of measurement
height measurement with tape and weight measurement with digital scale
4
Description
IL-6
Timepoint
Before the intervention, sixth mounth after intervention
Method of measurement
Elisa Exam
5
Description
IL-8
Timepoint
Before the intervention, sixth mounth after intervention
Method of measurement
Elisa Exam
6
Description
TNF-a
Timepoint
bBfore the intervention, sixth mounth after intervention
Method of measurement
Elisa Exam
Secondary outcomes
empty
Intervention groups
1
Description
People in intervention group will treat with pentoxifylline for six months at a rate of one tablet of 400 mg three times a day.
exercise and diet will advise for every one.
Category
Treatment - Drugs
2
Description
People in control group will treat with pelacebo for six months at a rate of one tablet three times a day.
exercise and diet will advise for every one.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat clinic
Full name of responsible person
Street address
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Science
Full name of responsible person
Dr Nadieh Baniasadi
Street address
Somaieh junction (Tahmasb abad), Shariaty street , Deputy of Research and Technology of Kerman University of Medical Sciences
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Science
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
Kerman Univercity of Medical Sciences
Full name of responsible person
Dr Nadieh Baniasadi
Position
Assisstant professor of gastroentrology
Other areas of specialty/work
Street address
Eman Highway, next to Zendan junction, Afzalipoor hospital
City
Kerman
Postal code
Phone
+34 33222250
Fax
Email
baniasadi.n@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman Univercity of Medical Sciences
Full name of responsible person
Dr Nadieh Baniasadi
Position
Assisstant professor of gastroentrology
Other areas of specialty/work
Street address
Eman Highway, next to Zendan junction, Afzalipoor hospital
City
Kerman
Postal code
Phone
+33 222250
Fax
Email
baniasadi.n@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman Univercity of Medical Sciences
Full name of responsible person
Dr Nadieh Baniasadi
Position
Assisstant professor of gastroentrology
Other areas of specialty/work
Street address
Eman Highway, next to Zendan junction, Afzalipoor hospital
City
Kerman
Postal code
Phone
+34 33222250
Fax
Email
baniasadi.n@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)