Evaluation of the effects of a Polyherbal compound on severity of steatosis and the levels of blood lipids and liver enzymes in patients with nonalcoholic fatty liver disease: A randomized controlled trial
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Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Exir Teb Zakaria company
Name of organization / entity - Persian: شرکت اکسیر طب ذکریا
Full name of responsible person - English: Dr Seyyed Abbas Zojaji
Full name of responsible person - Persian: دکتر سید عباس زجاجی
Street address - English: Pharmaceutical Technology Incubator of Mashhad university of medical science, Buali square
Street address - Persian: میدان بوعلی، مرکز رشد واحد های فناوری دانشگاه علوم پزشکی مشهد
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9196773117
Phone: +98 51 3711 2718
Fax:
Email: ExirTebeZakaria@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: The Zojaj Darman Toos Pharmaceutical Company
Name of organization / entity - Persian: شرکت دارویی زجاج درمان طوس
Full name of responsible person - English: Seyed Abbas Zojaji
Full name of responsible person - Persian: سید عباس زجاجی
Street address - English: Pharmaceutical Technology Incubator of Mashhad university of medical science, Buali square,Mashhad
Street address - Persian: مشهد، میدان بوعلی، مرکز رشد واحد های فناوری دانشگاه علوم پزشکی مشهد
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9196773113
Phone: +98 51 3711 2611
Fax:
Email: info@zojaj.club
Web page address:
contact.organization_id: Name of organization / entity - English: Exir Teb Zakaria companyThe Zojaj Darman Toos Pharmaceutical Company Name of organization / entity - Persian: شرکت اکسیر طب ذکریادارویی زجاج درمان طوس Full name of responsible person - English: Dr SeyyedSeyed Abbas Zojaji Full name of responsible person - Persian: دکتر سید عباس زجاجی Street address - English: Pharmaceutical Technology Incubator of Mashhad university of medical science, Buali squaresquare,Mashhad Street address - Persian: مشهد، میدان بوعلی، مرکز رشد واحد های فناوری دانشگاه علوم پزشکی مشهد City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 91967731179196773113 Phone: +98 51 3711 27182611 Fax: Email: ExirTebeZakariainfo@gmail.comzojaj.club Web page address:
Exir Teb Zakaria company
The Zojaj Darman Toos Pharmaceutical Company
Exir Teb Zakaria companyThe Zojaj Darman Toos Pharmaceutical Company
شرکت اکسیر طب ذکریا
شرکت دارویی زجاج درمان طوس
شرکت اکسیر طب ذکریادارویی زجاج درمان طوس
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Exir Teb Zakaria Company
Name of organization / entity - Persian: شرکت اکسیر طب ذکریا
Full name of responsible person - English: Seyyed Abbas Zojaji
Full name of responsible person - Persian: سید عباس زجاجی
Position - English: Managing Director
Position - Persian: Ph.D فارماکولوژی/مدیر عامل
Latest degree: phd
Area of specialty/work: 41
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
Street address - Persian: Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
City - English: Mashhad
City - Persian: Mashhad
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9177948564
Phone: +98 51 3502 4824
Mobile: +98 936 185 8500
Fax:
Email: exirtebzakaria@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Zojaj darman toos Pharmaceutical Company
Name of organization / entity - Persian: شرکت دارویی زجاج درمان طوس
Full name of responsible person - English: Seyyed Abbas Zojaji
Full name of responsible person - Persian: سید عباس زجاجی
Position - English: Managing Director
Position - Persian: Ph.D فارماکولوژی/مدیر عامل
Latest degree: phd
Area of specialty/work: 41
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
Street address - Persian: Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
City - English: Mashhad
City - Persian: Mashhad
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9177948564
Phone: +98 51 3502 4824
Mobile: +98 936 185 8500
Fax:
Email: zojajclub@gmail.com
Web page address: https://zojaj.club
contact.organization_id: Name of organization / entity - English: Exir Teb ZakariaZojaj darman toos Pharmaceutical Company Name of organization / entity - Persian: شرکت اکسیر طب ذکریادارویی زجاج درمان طوس Full name of responsible person - English: Seyyed Abbas Zojaji Full name of responsible person - Persian: سید عباس زجاجی Position - English: Managing Director Position - Persian: Ph.D فارماکولوژی/مدیر عامل Latest degree: phd Area of specialty/work: 41 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran Street address - Persian: Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran City - English: Mashhad City - Persian: Mashhad Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9177948564 Phone: +98 51 3502 4824 Mobile: +98 936 185 8500 Fax: Email: exirtebzakariazojajclub@gmail.com Web page address: https://zojaj.club
Protocol summary
Study aim
on severity of steatosis and the levels of blood lipids and liver enzymes in patients with nonalcoholic fatty liver disease
Design
Sixty-four patients with NAFLD were randomly divided into treatment and control groups (2:1 ratio).
Settings and conduct
The subjects for the study were derived from the Clinic of Internal Medicine, Emam-Reza Hospital, Mashhad University of Medical Sciences. The liver ultrasound and biochemical markers including the serum lipids, liver enzymes, and glucose were evaluated before starting the study and at the end of the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with nonalcoholic fatty liver disease with grade ≥ 2 of steatosis on sonography or grade 1 of steatosis + elevated serum alanine transaminase level
Intervention groups
Both control and group were advised to take healthy diet and exercise. The treatment group also received herbal capsules containing 400 mg of the mixture of Anethum graveolens, Citrus bigardia, Cynara scolymus, Portulaca oleracea, and Silybum marianum (2 capsules, thrice daily, for two months).
Main outcome variables
The primary outcome measures included change in grade of NAFLD in sonography and change in serum ALT level.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2015123025772N1
Registration date:2016-04-08, 1395/01/20
Registration timing:prospective
Last update:2020-08-17, 1399/05/27
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
2016-04-20, 1395/02/01
Actual recruitment end date
2019-02-20, 1397/12/01
Trial completion date
2019-03-19, 1397/12/28
Scientific title
Evaluation of the effects of a Polyherbal compound on severity of steatosis and the levels 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 on non alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with nonalcoholic fatty liver disease with grade ≥ 2 of steatosis on sonography or grade 1 of steatosis + elevated serum alanine transaminase level
Exclusion criteria:
Having special or chronic disease like auto immune diseases, hypothyroidism, lupus, renal dysfunction, cancers, heart diseases, and severe infections
Cirrhosis or Hepatitis B and C
Pregnancy and lactation
Unwillingness to continue treatment with herbal compound
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
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
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 Mashhad University of Medical Science
Street address
Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
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
Alanine transaminase (ALT)
Timepoint
Before intervention, two month after intervention
Method of measurement
Blood examination
2
Description
Steatosis of liver
Timepoint
Before intervention, two month after intervention
Method of measurement
Sonography
Secondary outcomes
1
Description
aspartate transaminase (AST)
Timepoint
Before starting study and 2 months after starting study
Method of measurement
Blood analysis (kit)
2
Description
fasting blood glucose
Timepoint
Before starting study and 2 months after starting study
Method of measurement
Blood analysis (kit)
3
Description
serum lipids
Timepoint
Before starting study and 2 months after starting study
Method of measurement
Blood analysis (kit) for total cholesterol and triglyceride
Intervention groups
1
Description
The treatment group received herbal capsules containing 400 mg of the mixture of Anethum graveolens, Citrus bigardia, Cynara scolymus, Portulaca oleracea, and Silybum marianum (2 capsules, thrice daily, for two months)> Both treatment and control group were advised to take healthy diet and exercise.
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
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
sabbaszojaji@gmail.com
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
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
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
70
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
The Zojaj Darman Toos Pharmaceutical Company
Full name of responsible person
Seyed Abbas Zojaji
Street address
Pharmaceutical Technology Incubator of Mashhad university of medical science, Buali square,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773113
Phone
+98 51 3711 2611
Email
info@zojaj.club
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Zojaj Darman Toos Pharmaceutical Company
Proportion provided by this source
30
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Zojaj darman toos Pharmaceutical Company
Full name of responsible person
Seyyed Abbas Zojaji
Position
Managing Director
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3502 4824
Fax
Email
zojajclub@gmail.com
Web page address
https://zojaj.club
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
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2278
Fax
Email
ghorbania@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Ghorbani
Position
Associate Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2278
Email
ghorbania@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available