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

A clinical trial with one intervention group and one control group, with parallel groups, double-blind, randomized with Random number table, phase 3 on 60 patients

After obtaining informed consent, patients are randomly divided into intervention and placebo groups.flaxseed oil in intrvention group and placebo in control group prescribed in a dose of 1g 2 times a day for 2 months.Demographic information of patients will be recorded. The study will perform at Qaim Hospital in a double-blind manner of patient and outcome assessor

Entry Conditions: Patient satisfaction AST and ALT level at least 1/5 times normal with ultrasound confirmation of fatty liver Age: 15 to 60 Non-entry conditions: 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

In the intervention group, flaxseed oil is prescribed in a dose of 1g 2 times a day for 2 months. In the control group, placebo is prescribed in a dose of 1g 2 times a day for 2 months.

Primary variables: AST, ALT, ALP, BILLI TOTAL AND DIRECT, Secondary variables: FBS, weight, height, Abdominal circumference, TG, CHOLESTROL, LDL, HDL, BMI

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.

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.

The data obtained in the study can be shared after making the participants unrecognizable.

After publishing the results, it will be possible to access the data.

The data will be available to medical researchers.

The use of data is unrestricted if it is not subject to plagiarism.

researchers can ask Dr. Delaram Omidvar to receive the data.

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.