In this randomized double blind clinical trial a traditional drug (Shirazi thyme) is compared with placebo in the treatment of non alcoholic fatty liver disease. Of the patients referred to Shahid Motahari and Faghihi clinics in Shiraz we select 90 persons with NAFLD by inclusion criteria. We measure anthropometric and laboratory parameters including FBS, Insulin, liver enzymes, lipid profile, and grade in sonography before intervention and 90 days later. Patients are divided into two 45 persons groups. Intervention group in addition to diet and exercise recommendations receive capsules containing 700 mg Shirazi thyme powder bid for 90 days.
Control group in addition to the same recommendations receive placebo capsules. Patients and physician are blind to intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120925447N1
Registration date:2016-10-16, 1395/07/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-16, 1395/07/25
Registrant information
Name
Nasrin dokht Zamani
Name of organization / entity
shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3635 8186
Email address
zamanina@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-05-22, 1395/03/02
Expected recruitment end date
2017-03-22, 1396/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Zataria multiflora Boiss in the treatment of non alcoholic fatty liver disease
Public title
The effect of Shirazi thyme in the treatment of fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: signed informed consent; age between 20 to 65 years old; BMI : 18 - 35; evidence of fatty liver in sonography; ALT equal or more than 45 in male and equal or more than 29 in female.
Exclusion criteria: pregnancy; lactation; alcohol consumption; diabetes mellitus; history of allergic reaction to Thyme; acute or chronic hepatic disease; treated or untreated malignancy; consumption of hepatotoxic drugs during six months ago or less; consumption of drugs with effect on the biochemical markers of this study during three months ago or less; hyper or hypothyroidism; renal insufficiency (Cr > 1.5 ).
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Street address
Central building of Shiraz University of Medical Sciences, Zand blvd.
City
Shiraz
Postal code
Approval date
2016-02-21, 1394/12/02
Ethics committee reference number
IR.SUMS.REC.1394.199
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver
ICD-10 code
K 76.0
ICD-10 code description
Non alcoholic fatty liver disease
Primary outcomes
1
Description
Alaninaminotransferase
Timepoint
Before intervention and three months after intervention
Method of measurement
Blood sampling
2
Description
Grade of fatty liver
Timepoint
Before intervention and three months after intervention
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before intervention and three months after intervention
Method of measurement
By manometer according to mmHg
2
Description
Fasting blood sugar
Timepoint
Before intervention and three months after intervention
Method of measurement
Blood sampling
3
Description
Aspartateaminotransferase
Timepoint
Before intervention and three months after intervention
Method of measurement
Blood sampling
4
Description
Body mass index
Timepoint
Before intervention and three months after intervention
Method of measurement
Scale and measuring tape
5
Description
Waist circumference
Timepoint
Before intervention and three months after intervention
Method of measurement
By measuring tape
6
Description
Hip circumference
Timepoint
Before intervention and three months after intervention
Method of measurement
By measuring tape
7
Description
Insulin
Timepoint
Before intervention and three months after intervention
Method of measurement
Blood sampling
8
Description
Lipid profile
Timepoint
Before intervention and three months after intervention
Method of measurement
Blood sampling
Intervention groups
1
Description
Intervention group : 700 mg (two 350 mg cap ) Shirazi thyme powder bid for 90 days
Category
Treatment - Drugs
2
Description
Control group : 700 mg (two cap 350 mg ) wheat powder bid for 90 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari cliinic
Full name of responsible person
Nasrin dokht Zamani
Street address
Motahari cliinic, Namazi square
City
Shiraz
2
Recruitment center
Name of recruitment center
Faghihi clinic
Full name of responsible person
Nasrin Dokht Zamani
Street address
Faghihi clinic, Zand Blvd.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Central building of Shiraz University of Medical Sciences, Zand blvd.
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 for research, 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
Faculty of Traditional Medicine, Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Dokht Zamani
Position
MD, PhD student of traditonal medicine
Other areas of specialty/work
Street address
Seventh floor, Faculty of Medicine, Imam Hossein square, Zand boulevard
City
Shiraz
Postal code
Phone
+98 71 3635 8186
Fax
Email
nzamani117@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endocrine research center, Shiraz University of Medical Sciences
Full name of responsible person
Mesbah Shams
Position
Associate professor ( subspecialist in Endocrinology )
Other areas of specialty/work
Street address
Namazi hospital, Namazi square
City
Shiraz
Postal code
Phone
+98 71 3647 4316
Fax
Email
shams@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Traditional Medicine, Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Dokht Zamani
Position
MD , PhD student of traditional medicine
Other areas of specialty/work
Street address
Seventh floor, Faculty of Medicine, Imam Hossein square, Zand boulevard
City
Shiraz
Postal code
Phone
+98 71 3635 8186
Fax
Email
nzamani117@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)