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IRCT20220521054947N1 IRCT 2022-08-12 Mashhad University of Medical Sciences Evaluation of effect of flaxseed oil on the non invasive liver marker's in patients with nonalcoholic fatty liver disease and comparison with placebo Evaluation of effect of flaxseed oil on the non invasive liver marker's in patients with nonalcoholic fatty liver disease and comparison with placebo 2022-08-16 anticipated 60 Complete https://irct.ir/trial/64052 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization with a table of random numbers using www.sealedenvelope.com In this method, a set of random numbers is generated and placed in a table. First, determine the direction of reading the numbers in the table. A numerical group is assigned to each intervention and control group. Then we choose a random number and move in the specified direction and record the numbers and assign them to different groups, Blinding description: Double-blind randomization of the subjects and outcome assessor by sealed envelopes. some envelopes will be prepared and each of the random sequences will be recorded on a card and the cards will be placed inside the envelopes. In order to preserve the random sequence, the pass number will be written on the outer surface of the envelopes in the same way. Finally, the envelopes will be sealed and placed inside the boxes. At the time of registration of the companies, according to the order of entry of qualified companies into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed. 3 Non-alcoholic fatty liver disease. Intervention 1: Intervention group: In the intervention group, flaxseed oil capsules made by Barij Essense Company is prescribed in a dose of 1g 2 times a day for 2 months (one capsule two times a day). Intervention 2: Control group: In the control group, placebo capsules made by Barij Essense Company is prescribed in a dose of 1g 2 times a day for 2 months (one capsule two times a day). Yes - There is a plan to make this available What will be shared: The data obtained in the study can be shared after making the participants unrecognizable. When: After publishing the results, it will be possible to access the data. To whom: The data will be available to medical researchers. Conditions: The use of data is unrestricted if it is not subject to plagiarism. Where to obtain: researchers can ask Dr. Delaram Omidvar to receive the data. How to obtain: The esteemed applicant must inform the above mentioned researcher of his / her details and the reason for the need for the data. After consulting with other researchers, He will announce his agreement or disagreement. Comments:
public Delaram Omidvar
Ahmadabad Boulevard, Mashhad
Mashhad Iran (Islamic Republic of) 9176999311 +98 51 3840 0000 omidvard971@mums.ac.ir Mashhad University of Medical Sciences scientific Delaram Omidvar
Ahmadabad Boulevard, Mashhad
Mashhad Iran (Islamic Republic of) 9176999311 +98 51 3840 0000 omidvard971@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patient satisfaction AST and ALT level at least 1/5 times normal with ultrasound confirmation of fatty liver Age: 15 to 60 15 years 60 years Both Consumption or history of alcohol consumption Positive serology of viral hepatitis (C, B) ANA or AMA, alpha 1 antitrypsin positive test, low serum ceruloplasin level or high level of ASMA and LKM14 antibodies Ferritin above 450 or 45% IRON / TIBC> 5 The patient develops an acute or chronic illness before or during the intervention that interferes with LFT (liver function tests) The patient take a drug before or during the intervention that has the potential to interfere with LFT Age less than 15 years and more than 60 years Pregnancy Taking herbal medicine K76.0 Other specified inflammatory liver diseases Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, flaxseed oil capsules made by Barij Essense Company is prescribed in a dose of 1g 2 times a day for 2 months (one capsule two times a day). Control group: In the control group, placebo capsules made by Barij Essense Company is prescribed in a dose of 1g 2 times a day for 2 months (one capsule two times a day). AST level changes. Timepoint: AST level measurement at baseline and at week 8. Method of measurement: blood sample. ALT level changes. Timepoint: ALT level measurement at baseline and at week 8. Method of measurement: blood sample. ALP level changes. Timepoint: ALP level measurement at baseline and at week 8. Method of measurement: blood sample. Bilirubin total and direct level changes. Timepoint: Bilirubin total and direct level measurement at baseline and at week 8. Method of measurement: blood sample. Fasting Blood Sugar. Timepoint: at baseline and at week 8. Method of measurement: blood sample. Weight. Timepoint: at baseline and at week 8. Method of measurement: Weighing scale. Height. Timepoint: at baseline and at week 8. Method of measurement: Meter. High-density lipoprotein (HDL). Timepoint: at baseline and at week 8. Method of measurement: Blood sample. Low-density lipoprotein (LDL). Timepoint: at baseline and at week 8. Method of measurement: Blood sample. Cholesterol. Timepoint: at baseline and at week 8. Method of measurement: Blood sample. Triglyceride. Timepoint: at baseline and at week 8. Method of measurement: Blood sample. Body mass index (BMI). Timepoint: at baseline and at week 8. Method of measurement: Body weight (kg) divided by the square of the body height(m). Mashhad University of Medical Sciences Approved 2022-04-12 Ethics committee of Mashhad University of Medical Sciences Azadi Square, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)