Protocol summary
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Study aim
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The purpose of this study was to evaluate the effectiveness of low-power laser in treating fatty liver with the aim of providing easier and more effective treatment.
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Design
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In a randomized, double blinded clinical trial, 60 patients with Grade 2 and 3 fatty liver with elevated liver enzymes confirmed by sonography were selected from 30 to 50 years old and divided into two groups: low-power laser and control group.
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Settings and conduct
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Patients in Shohada Tajrish hospital with Grade 2 and 3 fatty liver and elevated liver enzymes confirmed by sonography were selected in 30-50 years old patients and divided into two groups of low-level laser and control group. All patients were randomly assigned based on random numbers into two groups. The group assigned to the subject is buried in dark envelopes. The envelope will be opened by a doctor only after the initial assessment of each person, and the patient and the clinical evaluator of his treatment group won't be informed.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Grade 2 and 3 fatty liver with increased liver enzymes; age 30 to 50 years; Complete satisfaction to participate in the study and completion of treatment and follow up; Exclusion criteria: Patients with diabetes; Pregnant and lactating; Metabolic syndrome; Hyperlipidemia and Hypercholesterolemia; taking any medication in the last month; hepatitis; cardiovascular patients; hypertension; hyper and hypothyroidism; fibroma and polycystic ovary; hormonal disorders; age under 30 and over 50;
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Intervention groups
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Treatment group: low-level laser with a wavelength of 830 nm, a power of 35 mW, on four points (right upper, right lower, upper left, lower left of liver or four lobes of the liver) with different jules per patient (depth of the liver is measured in the primary ultrasound and from the energy divided by surface formula will be achieved) 3 times per week for 12 sessions.
Control group: Sham laser (silent laser) without output for blindness at the same points. All variables, including duration of radiation and the number of treatment sessions in the control group, will be exactly the same as the case group, and the treatment will be given by the same physician in this group.
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Main outcome variables
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Liver enzymes
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:
IRCT20111121008146N18
Registration date:
2018-01-08, 1396/10/18
Registration timing:
registered_while_recruiting
Last update:
2018-01-08, 1396/10/18
Update count:
1
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Registration date
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2018-01-08, 1396/10/18
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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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2017-09-23, 1396/07/01
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Expected recruitment end date
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2018-08-23, 1397/06/01
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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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Effectiveness of low-level laser in patients with Grade 2 and 3 fatty liver with increased liver enzymes
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Public title
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Evaluation of the effect of Laser in Fatty liver
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Fatty liver grade2 and 3 with increased liver enzymes
Age 30 to 50 years
Complete satisfaction to participate in the study and completion of the therapeutic and follow up process
Exclusion criteria:
Diabetes
Pregnant and lactating
Metabolic syndrome
Hyperlipidemia and hypercholesterolemia
Age under 30 and over 50 years
Taking any medication in a recent month
hepatitis
Cardiovascular patients
Hypertension
Hyperthyroidism and Hypothyroidism
Fibroma and polycystic ovaries
Hormonal disorders
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Age
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From 30 years old to 50 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
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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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Patients are divided into two groups with simple and individual randomized based on randomized 1: 1 random numbers. The group assigned to the subject is buried in dark envelopes. The envelope will be opened by a doctor only after the initial assessment of each person, and the patient and the clinical evaluator won't be informed.
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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 patient and the clinical evaluator will not be aware of the treatment group.
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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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2017-11-26, 1396/09/05
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1396.662
Health conditions studied
1
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Description of health condition studied
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Fatty liver grade 2 and 3 with increased liver enzymes
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ICD-10 code
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K77
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ICD-10 code description
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Liver disorders in diseases classified elsewhere
Primary outcomes
1
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Description
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Liver Enzyme Test
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Timepoint
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Before the intervention, the fourth session of the intervention and one month after the end of the intervention
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Method of measurement
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Laboratory tests
Intervention groups
1
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Description
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Intervention group: Low-level laser therapy with a wavelength of 830 nm, a power of 35 mW, on four points (right upper, right lower, upper left, lower left of liver or four lobes of the liver) with different jules according to the patient at each point (depth of the liver in The primary sonography is measured and from division of energy over the surface formula will be achieved) 3 times per week for 12 sessions.
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Category
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Treatment - Devices
2
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Description
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Control group: Sham laser (silent laser) is used for blindness at the same points as desired. All variables, including the duration of radiation and the number of treatment sessions in the control group, will be exactly the same as the case group, and the treatment will be given by the same physician in this group.
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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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Shahid beheshti 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