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Evaluation of the therapeutic effect of oral administration of cinnamon on Non-alcoholic steatohepatitis (NASH)

Protocol summary

Summary
Evaluation of the therapeutic effect of oral administration of cinnamon on Non-alcoholic steatohepatitis (NASH) Main objectives: The purpose of this study is to evaluate the therapeutic effect of cinnamon herbal medicine on non-alcoholic steatohepatitis, in comparison with vitamin E supplement. Design: Sixty patients voluntarily gave their signed informed consent and participated in this trial. Patients were divided into two thirty member groups by permutated block randomization. Inclusion and exclusion criteria: Patients who had no history of alcohol consumption or use of hepatotoxic drugs and other chronic hepatic or bile diseases, and also their disease has been diagnosed in ultrasonography and their ALT level was higher than 65 U/L, have been included in the study. If one of the volunteers during the study, becomes pregnant, indicates hypersensitivity reactions to cinnamon or by the end of the forth week has a rise in liver enzymes because of the medicine consumption, will be excluded from the study. Setting and conduct: At first, baseline laboratory tests were done and factors like liver enzymes level, especially ALT level, lipid profile and fasting blood sugar were measured and recorded. Interventions: For control group, a daily dose of 400 mg vitamin E, and for the other group, 250 mg of cinnamon, 4 times a day will be administered. Outcome measures: At the end of the forth and the eighth weeks the laboratory tests will be repeated and patients’ lipid profile and liver enzymes level, especially ALT, will be measured. To get more compliance and evaluate probable adverse drug reactions, patients will be contacted weekly.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062115587N9
Registration date: 2016-02-18, 1394/11/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-18, 1394/11/29
Registrant information
Name
Nasrin Naseri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4263
Email address
grc@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice –Chancellor of Shiraz University of Medical Sciences, Shiraz, Iran
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Evaluation of the therapeutic effect of oral administration of cinnamon on Non-alcoholic steatohepatitis (NASH)
Public title
Effect of cinnamon on liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria of the study: ALT level higher than 65U/L; Diagnosed fatty liver in ultrasonography; No alcohol and drug abuse; No history of chemotherapy in the past years; No history of other chronic liver diseases such as hepatitis B and hepatitis C, cirrhosis, bile diseases, autoimmune diseases, cancer and any genetic disorder that effects liver function such as Wilson’s disease; No history of lipid-lowering drug use; No pregnancy and breast-feeding; No use of vitamin E supplements; No use of drugs that caused fatty liver, like tetracycline, vitamin A, methotrexate, amiodarone, tamoxifen, etc.; No history of use of hepatotoxic drugs in the last 6 months; No long-term use of herbal drugs Exclusion criteria: If the patient indicates hypersensitivity reactions to cinnamon, becomes pregnant or not interested, and also if the level of liver enzymes rises at the end of the forth week due to cinnamon consumption, the patient will be excluded from the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients were divided into two 30 member groups by Permutated block randomization.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Postal code
Approval date
2015-05-17, 1394/02/27
Ethics committee reference number
IR.SUMS.REC.1394.30

Health conditions studied

1

Description of health condition studied
Non-alcoholic steatohepatitis
ICD-10 code
K75.8
ICD-10 code description
nonalcoholic steatohepatitis

Primary outcomes

1

Description
Reduction in ALT serum level
Timepoint
Before intervention, at the end of the fourth week of intervention, at the end of the eighth week of intervention
Method of measurement
Blood test and laboratory kits

2

Description
Reduction in AST serum level
Timepoint
Before intervention, at the end of the fourth week of intervention, at the end of the eighth week of intervention
Method of measurement
Blood test and laboratory kits

Secondary outcomes

1

Description
Lipid profile improvement
Timepoint
Before intervention, at the end of the fourth week of intervention, at the end of the eighth week of intervention
Method of measurement
Blood test and laboratory kits

Intervention groups

1

Description
Intervention group: Patients will receive 250 mg cinnamon capsules, prepared in Shiraz University of Medical Sciences, faculty of pharmacy, 4 times a day for two months. Related tests will be done at the beginning of the study and the end of every four weeks. To get more compliance and evaluate probable adverse drug reactions, patients will be contacted weekly. Control group: Will receive 400 mg Vitamin E capsule, once daily for two months. Related tests will be done at the beginning of the study and the end of every four weeks. To get more compliance and evaluate probable adverse drug reactions, patients will be contacted weekly.
Category
Treatment - Drugs

2

Description
Control group: Patients will receive 400 mg Osve Vitamin E capsule, once daily for two months. Related tests will be done at the beginning of the study and the end of every four weeks. To get more compliance and evaluate probable adverse drug reactions, patients will be contacted weekly.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Polyclinic
Full name of responsible person
Elham Mansourabadi
Street address
Motahari Polyclinic, Namazi Square, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice –Chancellor of Shiraz University of Medical Sciences
Full name of responsible person
Seyyed Basir Hashemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice –Chancellor of Shiraz 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
Gastroenterohepatology Research Center of Shiraz
Full name of responsible person
Maryam Moeeni
Position
Gastroenterohepatology Subspecialist
Other areas of specialty/work
Street address
Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3612 5518
Fax
Email
moeenim@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gastroenterohepatology Research Center of Shiraz
Full name of responsible person
Maryam Moeeni
Position
Gastroenterohepatology Subspecialist
Other areas of specialty/work
Street address
Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3612 5518
Fax
Email
moeenim@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Gastroenterohepatology Research Center of Shiraz
Full name of responsible person
Nasrin Naseri
Position
Other areas of specialty/work
Street address
Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3628 1442
Fax
Email
n_naseri65@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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