Evaluation of the effects of a Polyherbal compound on the level of blood lipids and liver enzymes in patients with nonalcoholic fatty liver disease: A randomized controlled trial
(1) Objectives: The effect of a herbal compound on the amount of liver enzymes and blood fat in patients with nonalcoholic fatty liver
(2) Design (study groups and phase, sample size, blinding, randomization)
Study groups consist of 64 men and women with fatty liver disease in two experimental and control groups, each group consist of 32 patients. Trial is a single blind, Randomized controlled and Single-center study trial. This trial is a phase 1 clinical trial.
(3) Setting and conduct
Both of experimental and control groups take 2 capsules of drug three times daily for two months.
(4) Participants including major eligibility criteria
a- The desire to participate in the study, b- High level of liver enzyme ALT greater than 1.5 times normal, c- The degree of steatosis on sonography higher than 1, d- No history of alcohol abuse, e- Having no acute or chronic disease.
(5) Intervention
Improving chemical drug treatment of fatty liver disease.
(6) Main outcome measures (primary and secondary outcome variables)
Primary outcome variables: reducing hepatic enzymes, reducing the level of blood triglyceride and total cholesterol, reduce in liver steatosis by sonography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015123025772N1
Registration date:2016-04-08, 1395/01/20
Registration timing:prospective
Last update:
Update count:2
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Seyyed Abbas Zojaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2717
Email address
zojajia881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical science, Exir teb zakaria company
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-06-15, 1395/03/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of a Polyherbal compound on the level of blood lipids and liver enzymes in patients with nonalcoholic fatty liver disease: A randomized controlled trial
Public title
Evaluation of the effect of a herbal mixture at treatment of non alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study; increasing ALT serum level more than 1.5 times of normal; steatosis degree more than 1 time of normal level; No history of alcohol
Exclusion criteria: Having special or chronic disease like auto immune diseases, hypothyroidism, lupus, renal dysfunction, cancers, heart diseases; Having infections or acute diseases; Hepatitis A,B or C; Psychological disease; Pregnancy and lactation; Having special drug regimen; Unwillingness to continue treatment
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Science
Street address
Mashhad Medical School, Mashhad University Pardis
City
Mashhad
Postal code
Approval date
2015-06-17, 1394/03/27
Ethics committee reference number
IR.MUMS.fm.REC.1394.114
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver desease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Total cholestrol
Timepoint
Before intervention, two month after intervention
Method of measurement
Blood examination
2
Description
VLDL
Timepoint
Before intervention, two month after intervention
Method of measurement
Blood examination
3
Description
LDL
Timepoint
Before intervention, two month after intervention
Method of measurement
Blood examination
4
Description
HDL
Timepoint
Before intervention, two month after intervention
Method of measurement
Blood examination
5
Description
Triglyceride
Timepoint
Before intervention, two month after intervention
Method of measurement
Blood examination
6
Description
Fasting blood sugar
Timepoint
Before intervention, two month after intervention
Method of measurement
Blood examination
7
Description
ALT
Timepoint
Before intervention, two month after intervention
Method of measurement
Blood examination
8
Description
AST
Timepoint
Before intervention, two month after intervention
Method of measurement
Blood examination
9
Description
Bilirubin
Timepoint
Before intervention, two month after intervention
Method of measurement
Blood examination
10
Description
Blood urea
Timepoint
Before intervention, two month after intervention
Method of measurement
Blood examination
11
Description
Blood creatinine
Timepoint
Before intervention, two month after intervention
Method of measurement
Blood examination
12
Description
Steatosis of liver
Timepoint
Before intervention, two month after intervention
Method of measurement
Sonography
13
Description
Body Mass Index
Timepoint
Before intervention, two month after intervention
Method of measurement
Calculation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Take 2 capsules equal to 2 g from herbal mixture after every meal ( three times daily) for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group:
Take 2 capsules equal to 2 g from placebo after every meal ( three times daily) for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital Special Clinic
Full name of responsible person
Seyyed Abbas Zojaji
Street address
Emam Reza Hospital, Emam Reza Square
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice chancellor for Research of Mashhad University of Medical Science, Ghoreyshi Building, Daneshgah Avenue
City
Mashhad
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, Mashhad University of Medical Science
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Exir Teb Zakaria company
Full name of responsible person
Dr Seyyed Abbas Zojaji
Street address
Pharmaceutical Technology Incubator of Mashhad university of medical science, Buali square
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Exir Teb Zakaria company
Proportion provided by this source
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
Exir Teb Zakaria Company
Full name of responsible person
Seyyed Abbas Zojaji
Position
Ph.D of Pharmacology/CEO
Other areas of specialty/work
Street address
No 3, Goldis 3 avenue, Ladan boulevard
City
Mashhad
Postal code
Phone
+98 51 3502 4824
Fax
Email
exirtebzakaria@gmail.com
Web page address
www.etzakaria.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhsad Medical School, Pharmacological Research Center of Medicinal Plants
Full name of responsible person
Ahmad Ghorbani
Position
Assistant Professor/ Physiology Ph.D
Other areas of specialty/work
Street address
Pharmacological Research Center of Medicinal Plants, Mashhad Medical School, Mashhad University Pardis
City
Mashhad
Postal code
Phone
+98 51 3711 2717
Fax
Email
ghorbania@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)