Protocol summary

Study aim
Determination of the efficacy of traditional drug based on Coriandrum sativum on the ultrasound grade and serum level of liver enzymes in patients with non-alcoholic fatty liverse in patients referred to Besat Clinic in Kerman in 1399-1400
Design
Clinical trial with control group, with parallel groups, double blind, randomized, phase 3 on 80 patients. The quadruple block method was used for randomization.
Settings and conduct
This study is a randomized clinical trial in patients referred to Besat Clinic in Kerman with symptoms of metabolic syndrome. The patients are randomly divided into two groups of drugs and placebo based on the quadruple block method. Due to the similarity of the drug and placebo, patients do not know which group they are in. On the other hand, drug and placebo coding is done by the pharmacist and the researcher is unaware of how patients are assigned to the groups until the end of the study. In both groups, before the start of the study and after the end of the liver ultrasound treatment course, the serum levels of liver enzymes including AST, ALT and ALP are evaluated and compared.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Non-alcoholic fatty liver based on ultrasound (grades 1 to 3) Age 18 to 70 years Informed consent of the patient; Exclusion criteria: Pregnancy or breastfeeding Alcoholic Fatty liver Smoking Taking hypoglycemic, hypolipidemic and anti-inflammatory drugs Other diseases such as viral hepatitis, coronary artery disease, kidney, lung and thyroid diseases
Intervention groups
The intervention group is given four 500 mg tablets daily (two in the morning and two at bedtime) of traditional medicine based on coriander, and the control group is given four 500 mg placebo tablets containing starch powder for two months.
Main outcome variables
Fatty liver ultrasound grade, serum levels of ALT, AST and Alk-P enzymes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131214015790N3
Registration date: 2020-12-06, 1399/09/16
Registration timing: registered_while_recruiting

Last update: 2020-12-06, 1399/09/16
Update count: 0
Registration date
2020-12-06, 1399/09/16
Registrant information
Name
Mehrzad Mehrbani
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 218877352125
Email address
mzmehrbani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of traditional medicine based on Coriandrum sativum in comparison with placebo on the ultrasound grade and serum level of liver enzymes in patients with non-alcoholic fatty liver
Public title
Evaluation of the efficacy of a traditional product on fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of diagnosis of non-alcoholic fatty liver based on ultrasound (grades 1 to 3) Age 18 to 70 years Written and informed consent of the patient
Exclusion criteria:
Pregnancy or breastfeeding Fatty liver secondary to alcohol consumption Smoking Taking hypoglycemic, hypolipidemic and anti-inflammatory drugs (any drug that affects liver function) Other diseases such as viral hepatitis, coronary artery disease, kidney, lung and thyroid diseases
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a double-blind clinical trial that is performed on patients with fatty liver in patients referred to Besat Clinic in Kerman in 1399. Patients are randomly assigned to the drug and placebo groups based on the quadruple block method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the similarity of the drug and placebo, patients do not know which group they are in. On the other hand, drug and placebo coding is done by the pharmacist and the researcher is unaware of how patients are assigned to the groups until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research, Kerman University of Medical Sciences
Street address
Medical University Campus, Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-07-06, 1399/04/16
Ethics committee reference number
IR.KMU.REC.1399.261

Health conditions studied

1

Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
K75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)

Primary outcomes

1

Description
Fatty liver ultrasound grade
Timepoint
Beginning and end of the study (end of the second month)
Method of measurement
Ultrasound in the same radiology center

2

Description
Serum AST level
Timepoint
Beginning and end of the study (end of the second month)
Method of measurement
Beckman DU spectrophotometer

3

Description
Serum ALT level
Timepoint
Beginning and end of the study (end of the second month)
Method of measurement
Beckman DU spectrophotometer

4

Description
Serum Alk-P level
Timepoint
Beginning and end of the study (end of the second month)
Method of measurement
Beckman DU spectrophotometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group is given four tablets daily (two in the morning on an empty stomach and two at night at bedtime) of traditional medicine based on coriander for two months. These pills contain Coriandrum sativum seeds, Cichorium intybus L. seeds, Lactuca sativa seeds, Fumaria officinalis, Ziziphus jujuba, Zataria multiflora leaves, Cassia angustifolia leaves and Rheum palmatum root in equal proportions.
Category
Treatment - Drugs

2

Description
Control group: The control group is given four 500 mg placebo tablets (two in the morning on an empty stomach and two at night at bedtime) containing starch powder for two months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Clinic
Full name of responsible person
Mehrzad Mehrbani
Street address
Ebn-e-Sina Ave., Jahad Blvd.
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 8740
Email
sit@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abass Pardakhti
Street address
Ebn-e-Sina Ave., Jahad Blvd.
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@hotmail.com
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 Sciences
Proportion provided by this source
100
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

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehrzad Mehrbani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Persian Medicine, Jomhuri Eslami Blvd.
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0360
Email
mzmehrbani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehrzad Mehrbani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Persian Medicine, Jomhuri Eslami Blvd.
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0360
Email
mzmehrbani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehrzad Mehrbani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Persian Medicine, Jomhuri Eslami Blvd.
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0360
Email
mzmehrbani@yahoo.com

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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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