Effect of Complementary Therapy with Hydro-Ethanolic Extract of Aerial Parts of Purslane on Clinical and Paraclinical Findings in Patients with Nonalcoholic Fatty Liver Disease

Determining the effect of supplementation with hydroethanolic extract of portulaca oleracea on clinical and laboratory findings in patients with non-alcoholic fatty liver

This study is a double-blind RCT that investigates the effect of supplementation with hydro-ethanolic extract of aerial parts of Purslane for eight weeks at daily dose of 700 (two capsules of 350mg) on lipid profile, inflammatory markers and oxidative stress and nutritional status and liver fibrosis and steatosis status in NAFLD patients. Study groups: intervention and control (each n = 27).

Demographic information and medical history and anthropometric indices, BP and body composition (BIA), three-day food recall and IPAQ will be measured before, between and after the study. 5 cc of blood is taken (before & after the intervention) after 12-hour fasting, to evaluate laboratory indicators. All patients will be given hypocaloric diet. Mediterranean diet recommendations and physical activity will be given. At the end, changes in the status of steatosis and liver fibrosis in patients will be assessed.

Inclusion: 18 to 65 years, diagnosis of hepatic steatosis, filling out the consent form exclusion: pregnancy, lactation, morbidobesity, history of alcohol consumption or hepatotoxic drugs, any immunodeficiency disorder, HIV, liver or kidney failure, other liver diseases, bariatric surgery

Intervention group: lifestyle interventions (diet therapy + PA), supplementation with hydro-ethanolic extract of aerial parts of Purslane with 2 capsules each having 350 mg daily for 8 weeks.

Assessment of anthropometric indices, body composition, serum concentration of MDA, GSH, TC, HDL-C, LDL-C, TG, FBS and insulin, ALT, ALP, AST,GGT,ESR,CBC Diff and hs-CRP and 3-day food recall, IPAQ and steatosis and hepatic fibrosis status.

According to the Two Intervention and Control Groups, the Volume of each Block will be Four. Then Write A List of Blocks and Assign Numbers to them. For example (AABB (1)-ABAB (2)-ABBA (3)-BBAA (4)-BABA (5)-BAAB (6) which According to the Sample Size 27 The Number of People in each Group will be 9 blocks, then the Random Nnumbers between one and 9 will be Selected According to the Randomization Site Randomaize.com, and Finally the List of Treatment Allocation Based on Random Numbers will be Written on the Envelopes Containing each Block. Randomization type: Blocked How to make 4 blocks: We use letters depending on how many groups are studied For two groups of which 6 modes of movement are possible. A, B According to the formula, if there are two groups, a four-letter block for two letters and Formula 1 are used. 1. 4! (1 * 2 * 3 * 4) / [2! (1 * 2)] * [4-2]! = 3 * 4/2 = 6 states Allocation Concealment allocation method: Use of opaque SNOSE sealed envelopes (sequentially numbered, opaque, sealed envelopes) In this way, the envelopes will be prepared and printed by one of the team members and random numbers and will be placed inside the envelope. The lid of the envelope will be closed and its contents will not be visible from the outside. Then, the purpose of the study is explained to the person who meets the conditions, and the person, if desired, signs the informed consent form and takes an envelope, and then opens it and enters the intervention or control group based on the contents of the envelope.

Due to the use of placebo similar to the intervention treatment, the physician associated with the participants and participants will not be informed of the assigned treatment. Also, the analyst will be unaware of the treatment assigned to the two groups. Finally, after analyzing the data, the researcher who prepared the packages reveals codes A and B. With the exception of the pharmacist, none of the participants, researchers, or analysts will be aware of the drug or placebo until the end of the study. In this way, the groups are identified only by codes A and B. The drugs are prepared in the same packaging and in the same form and are packaged by a person in a pharmaceutical company that is out of research in the form of A and B coding packages. The code password is stored securely in the system so that the codes can be unlocked after data collection.

I will inform at the end of the study.

I will inform at the end of the study.

I will inform at the end of the study.

I will inform at the end of the study.

I will inform at the end of the study.

I will inform at the end of the study.