survey the effect of alpha-lipoic acid supplementation on some biomarkers of oxidative stress and inflammation, clinical symptoms and quality of life in patients with ulcerative colitis: a clinical trial

Determining the effect of alpha lipoic acid supplementation on some biomarkers of oxidative and inflammatory stress, clinical symptoms and quality of life in patients with ulcerative colitis.

A clinical trial with control group including a sample size of 56 people, with parallel group, double-blind, randomized

Referring to the gastroenterology clinic and hospital, 56 patients were selected based on inclusion and exclusion criteria, and they were randomized into intervention and control groups—blinding of patients and researchers and coding by a third party who does not know the details.

A gastroenterologist diagnoses this disease based on clinical, colonoscopy and histopathological findings. Age 25 to 55 years, body mass index in the range of 18.5 to 27, no cancer, other autoimmune and inflammatory diseases, suffering from Mild to moderate form of the disease, not taking antioxidant supplements in the last two months, desire to participate in the intervention and not being pregnant, breastfeeding, or taking oral contraceptives in women are the entry criteria. The exclusion criteria are the relapse of the disease that leads to hospitalization, unwillingness to Continue to participate in the intervention, and changing the drug dose during the study.

Study groups include alpha lipoic acid and placebo consumer groups

IL-1B _ IL-8 _ MDA _ SOD _ clinical symptoms _ quality of life _ physical activity

The allocation of patients to the intervention and control groups is carried out using the block randomization method, employing blocks of sizes 4, 6, and 8. A random list of 56 rows is generated using the Sealed Envelope computer program (each row's information is assigned to one of the participants). Of these 56 rows, 28 are randomly assigned to treatment A (drug) and the other 28 to treatment B (placebo). Since the software assigns a three-character code (two letters and one number) to each row, an individual outside the research team labels 56 identical drug bottles according to the assigned codes. They place the corresponding treatment (supplement or placebo) in each bottle according to the table and provide the labeled bottles to the researcher. Then, based on the order of participants entering the study, each individual with a specific code is given the bottle with the corresponding code.

This study will use the double-blind method to reduce the possibility of information bias. In this way, patients and the researchers will be kept unaware of the type of treatment assigned to the subjects. For this purpose, someone outside the study will label alpha lipoic acid and placebo packages.

The person's information will be confidential and the results will be as collective statistics.