Protocol summary
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Study aim
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on severity of steatosis and the levels of blood lipids and liver enzymes in patients with nonalcoholic fatty liver disease
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Design
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Sixty-four patients with NAFLD were randomly divided into treatment and control groups (2:1 ratio).
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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).
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Main outcome variables
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The primary outcome measures included change in grade of NAFLD in sonography and change in serum ALT level.
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2016-04-08, 1395/01/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Mashhad university of medical science, Exir teb zakaria company
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Expected recruitment start date
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2016-04-20, 1395/02/01
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Expected recruitment end date
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2016-06-15, 1395/03/26
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Actual recruitment start date
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2016-04-20, 1395/02/01
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Actual recruitment end date
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2019-02-20, 1397/12/01
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Trial completion date
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2019-03-19, 1397/12/28
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Scientific title
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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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Public title
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Evaluation of the effect of a herbal mixture on non alcoholic fatty liver disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
64
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-06-17, 1394/03/27
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Ethics committee reference number
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IR.MUMS.fm.REC.1394.114
Health conditions studied
1
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Description of health condition studied
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Non alcoholic fatty liver desease
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ICD-10 code
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K76.0
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ICD-10 code description
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Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
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Description
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Alanine transaminase (ALT)
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Timepoint
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Before intervention, two month after intervention
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Method of measurement
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Blood examination
2
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Description
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Steatosis of liver
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Timepoint
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Before intervention, two month after intervention
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Method of measurement
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Sonography
Secondary outcomes
1
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Description
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aspartate transaminase (AST)
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Timepoint
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Before starting study and 2 months after starting study
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Method of measurement
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Blood analysis (kit)
2
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Description
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fasting blood glucose
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Timepoint
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Before starting study and 2 months after starting study
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Method of measurement
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Blood analysis (kit)
3
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Description
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serum lipids
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Timepoint
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Before starting study and 2 months after starting study
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Method of measurement
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Blood analysis (kit) for total cholesterol and triglyceride
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for Research, Mashhad University of Medical Science
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Proportion provided by this source
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70
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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The Zojaj Darman Toos Pharmaceutical Company
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Proportion provided by this source
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30
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable