Protocol summary
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Study aim
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The aim of this study was to prescribe "Berberpim®" syrup to patients with Non-alcoholic fatty liver disease and evaluate its effectiveness in a randomized, double-blind, placebo-controlled clinical trial.
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Design
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In this study, 46 patients were randomly assigned to take "Berberpim®" syrup (intervention) or placebo (control) for 3 months. In this way, 10 cc of syrup is used twice daily.
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Settings and conduct
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This study was performed randomly on 46 patients including intervention and control groups in Ejlalieh Clinic of Kermanshah University of Medical Sciences. In this way, 10 cc of syrup is used twice daily. Blinding is performed for patients, clinical caregivers and outcome assessors. Randomization is also done using blocks of 4 and 6.
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Participants/Inclusion and exclusion criteria
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The main inclusion criteria are the following: age over 18 years; patients to sign a written consent and have the necessary cooperation during the study and patients who have the disease according to the results of ultrasound, clinical interview, increase in liver enzymes. Main exclusion criteria also include: patients with Hepatitis; Wilson's disease; people who drink alcohol; people with type I diabetes and type II diabetes who have been taking drugs for a year and people taking drugs that affect the level of liver enzymes such as Statins and Acetaminophen in high doses.
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Intervention groups
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Intervention: Twice daily oral administration of 10 cc of "Berberpim®" syrup for 3 months
Control: Twice daily oral administration of 10 cc of placebo syrup for 3 months
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Main outcome variables
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Biochemical factors (serum levels of CRP; ESR; LDL; HDL; ALT; AST; triglycerides; cholesterol; platelets; vitamin D; fasting blood sugar) and anthropometric factors (BMI; weight and abdominal circumference)
General information
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Reason for update
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Due to the need to determine the grade of the disease as one of the criteria for inclusion in the study and change of the disease center, the mentioned cases were corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210814052178N1
Registration date:
2021-09-02, 1400/06/11
Registration timing:
prospective
Last update:
2021-11-01, 1400/08/10
Update count:
1
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Registration date
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2021-09-02, 1400/06/11
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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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2021-11-06, 1400/08/15
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Expected recruitment end date
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2022-05-05, 1401/02/15
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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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Formulation and evaluation of the effectiveness of "Berberpim®" syrup in patients with Non-alcoholic fatty liver disease: A randomized clinical trial study
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Public title
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The effect of "Berberpim®" syrup 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:
Age over 18 years
Patients with grade I and II Non-alcoholic fatty liver disease according to the results of ultrasound, clinical interview, increase in liver enzymes and elimination of other causes this disease affects Non-alcoholic fatty liver
Exclusion criteria:
Patients with Hepatitis
Wilson's disease
People who drink alcohol
People with type I diabetes and type II diabetes who have been taking the drug for a year
Consumers of drugs that affect the level of liver enzymes such as Statins and Acetaminophen in high doses
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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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3
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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:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, two groups that meet the inclusion criteria are randomly assigned to the drug and placebo groups. Randomization process is done using 4 and 6 blocks. Blocking will be done by online randomization software www.sealedenvelope.com
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The double-blind method is used for blinding. The list of intervention groups identified in this process remains with the coordinator. The person responsible for evaluating the entry / exit criteria and registration of individuals will not be aware of this process. None of the patients and the evaluator will know the type of treatment
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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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2021-10-19, 1400/07/27
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Ethics committee reference number
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IR.KUMS.REC.1400.543
Health conditions studied
1
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Description of health condition studied
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Non-alcoholic fatty liver disease
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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
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Blood Test
2
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Description
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Aspartate transaminase
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Blood Test
3
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Description
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Triglyceride
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Blood Test
4
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Description
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Cholesterol
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Blood Test
5
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Description
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High-density lipoprotein
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Blood Test
6
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Description
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Low-density lipoprotein
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Blood Test
7
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Description
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Fasting blood sugar
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Blood Test
8
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Description
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Platelets
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Blood Test
9
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Description
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Vitamin D
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Blood Test
10
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Description
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C-Reactive Protein
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Blood Test
11
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Description
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Erythrocyte Sedimentation Rate
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Blood Test
12
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Description
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Weight
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Weighing scales
13
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Description
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Abdominal circumference
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Tapeline
14
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Description
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Body mass index
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Timepoint
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Before intervention, 3 months after intervention
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Method of measurement
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Special formula
Intervention groups
1
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Description
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Intervention group: Twice daily use 10 cc of Berberpim syrup to move for 3 months
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Category
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Treatment - Drugs
2
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Description
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Control group: Twice daily use of 10 cc placebo for 3 months
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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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Kermanshah University of Medical Sciences
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Proportion provided by this source
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100
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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
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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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available