Protocol summary
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Study aim
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Investigating the effect of berberis integrimma extract on disease severity and inflammatory indices in patients with ulcerative colitis
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Design
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Parallel-groups, double-blind, randomized clinical controlled trial
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Settings and conduct
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60 patients with non-alcoholic fatty liver disease will be randomly assigned to intervention and control groups. In the intervention group, participants will receive 2 tablespoons of berberis integerimna extract daily. In the placebo group, participants consume the same amount of placebo. The study period will be 12 weeks. The DASH diet will be prescribed for both groups according to the characteristics of the participants. Also, to control participants in terms of taking supplements and placebo and prevent the samples from falling, the follow-up of patients would occur every two weeks by phone.
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Participants/Inclusion and exclusion criteria
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Entry criteria: age 18 years and older; diagnosis of the disease by ultrasound; ALT >30 IU/L in men and ALT >19 IU/L in women; BMI greater than 18.5 and less than 30.
Non-entry criteria: pregnancy or breastfeeding; alcohol consumption; history of diseases including liver cirrhosis; viral hepatitis; cardiovascular diseases; cancer; relapse and hospitalization of the patient; allergy to barberry.
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Intervention groups
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In the intervention group, participants receive 2 tablespoons of berberis integerimna extract daily. In the placebo group, participants consume the same amount of placebo. The study period will be 12 weeks.
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Main outcome variables
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changes in the severity of liver steatosis; changes in the severity of liver fibrosis; Serum levels of liver enzymes (ALT, AST, ALP, GGT)
General information
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Reason for update
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1. Cooperation and sponsorship of Sanabel Daru Company to prepare the extract
2. Using berberis integerrima syrup instead of berberis integerrima capsules
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210427051098N6
Registration date:
2024-02-03, 1402/11/14
Registration timing:
prospective
Last update:
2024-11-10, 1403/08/20
Update count:
1
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Registration date
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2024-02-03, 1402/11/14
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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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Expected recruitment start date
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2024-05-21, 1403/03/01
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Expected recruitment end date
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2025-05-22, 1404/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of berberis integerrima extract on liver enzymes, liver steatosis and fibrosis in patients with non-alcoholic fatty liver disease (NAFLD) following the DASH diet: a double-blind randomized clinical trial.
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Public title
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The effects of berberis integerrima extract on the non-alcoholic fatty liver disease (NAFLD)
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 18 and older
Diagnosis of the disease by ultrasound with a standard method
ALT >30 IU/L in men and ALT >19 IU/L in women
BMI higher than 18.5 and less than 30
Exclusion criteria:
Taking corticosteroids
Pregnancy and breastfeeding
Alcohol consumption (men: ethanol > 140 g per week, women: ethanol > 70 g per week)
History of diseases including liver cirrhosis, viral hepatitis, cardiovascular diseases, cancer
Medication history including corticosteroids, non-steroidal anti-inflammatory drugs, drugs affecting blood sugar, lipid profile, body weight and liver function.
Disease relapse and patient hospitalization
Barberry allergy
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Age
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From 18 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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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The random allocation between two groups will perform using Random allocation version 2 software. The random sequence will generate with this software using a simple random allocation method, and each number will allocate to an intervention group A or B. Allocation concealment will perform by calling or sending message to a third-person who is unaware of intervention.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators and data collectors will be blinded to the study groups. Allocation concealment will perform by calling or sending message to a third-person who is unaware of intervention.
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Placebo
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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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2023-11-20, 1402/08/29
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Ethics committee reference number
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IR.SSU.SPH.REC.1402.105
Health conditions studied
1
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Description of health condition studied
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Non-alcoholic fatty liver disease (NAFLD)
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ICD-10 code
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K75.81
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ICD-10 code description
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Nonalcoholic steatohepatitis (NASH)
Primary outcomes
1
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Description
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Serum levels of alanine transaminase enzyme
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Timepoint
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Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
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Method of measurement
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Enzymatic method
Secondary outcomes
1
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Description
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Severity of hepatic steatosis
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Timepoint
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Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
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Method of measurement
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Fibroscan analysis
2
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Description
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Severity of liver fibrosis
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Timepoint
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Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
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Method of measurement
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Fibroscan analysis
3
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Description
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Severity of liver stiffness
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Timepoint
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Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
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Method of measurement
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Fibroscan analysis
4
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Description
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Controlled Attenuation Parameter (CAP)
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Timepoint
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Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
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Method of measurement
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Fibroscan analysis
5
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Description
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Serum levels of aspartate aminotransferase
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Timepoint
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Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
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Method of measurement
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Enzymatic method
6
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Description
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Serum levels of alkaline phosphatase
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Timepoint
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Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
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Method of measurement
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Enzymatic method
7
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Description
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Serum levels of gammaglutamyltransferase
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Timepoint
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Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
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Method of measurement
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Enzymatic method
Intervention groups
1
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Description
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Intervention group: In the intervention group, participants will receive 2 tablespoons of barberry extract (Prepared by Sanabel Daru Company) for 12 weeks. The DASH diet will be prescribed for both groups according to their characteristics and individual requirements.
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Category
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Treatment - Other
2
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Description
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Control group: In the placebo group, participants will receive a placebo syrup with a similar appearance to the intervention syrup, for 12 weeks.
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Category
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Placebo
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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Yazd University of Medical Sciences
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Proportion provided by this source
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50
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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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Sanabel Daroo Company
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Proportion provided by this source
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50
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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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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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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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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available