Investigating the effect of chitosan supplementation on non-alcoholic fatty liver steatosis patients

Determining the effect of chitosan supplementation on steatosis in patients with non-alcoholic fatty liver disease

Clinical trial with control group, double blind, randomized, phase 3 on 60 patients. Sealed and waxed opaque envelopes were used for randomization.

In all clinics covered by Mashhad University of Medical Sciences, posters and information related to the project will be posted. People interested in the plan are selected after visiting the gastroenterology clinic and an initial examination by a gastroenterology and fatty liver specialist, and are referred to the radiology clinic, and after the definitive diagnosis of fatty liver, they are referred to the nutrition clinic. The plan is explained to the people who have the necessary conditions and criteria to enter the study, and after obtaining written consent, they are selected and entered the study.

Inclusion Criteria: Age 18 to 65 years; Fatty liver grade 1 and 2; Absence of morbid obesity; Lack of breastfeeding and pregnancy; No alcohol consumption; lack of immunity; Absence of liver and kidney failure; not taking hepatotoxic drugs; No allergy to marine products; No bariatric surgery Exclusion criteria: pregnancy and breastfeeding; morbid obesity; alcohol consumption; suffering from autoimmune disorders; liver or kidney failure; use of hepatotoxic drugs; History of allergy to seafood

Intervention group: They will receive six chitosan supplements every day for 60 days (2 months). Control group: They will receive six placebo capsules every day for 60 days (2 months).

Severity of hepatic steatosis; body fat percentage; amount of physical activity; the amount of energy intake; the amount of body mass; waist size

Allocation concealment Allocation concealment is a technique to ensure that the random allocation process is truly random and unbiased. RCTs use allocation concealment to decide which patients will receive the real drug and which will receive a placebo. In this study, the researcher wants all study groups to have equal sample size, so she uses limited randomization of the block randomization type. in such a way that: We name two treatment methods (intervention and placebo) with letters A and B. We consider each block as four. For a sample size of 60 people, 15 blocks of 4 are needed. For blocks of 4, there will be the following six different states (permutations), similar to the order below: AABB(1) -ABAB(2)- ABBA(3) -BBAA(4) -BABA(5) -BAAB(6) With the help of Randomaize.com software, we choose random numbers between 1 and 6. 15 We write down the combination corresponding to the numbers: 6 2 5 4 3 5 5 6 5 1 3 2 5 5 3 Then, when each participant enters the study, they will be treated according to the order of the letter (A or B). Use of sealed opaque envelopes with random sequence:(Sequentially numbered, sealed opaque envelopes) This method is one of the common methods of hiding random allocation, which is abbreviated as the method SNOSE. In this method, first a random sequence is created by one of the mentioned methods, then based on the sample size of the research, a number of letter envelopes with aluminum wrappers (in order to make the contents of the envelopes unclear) are prepared and each of the generated random sequences is recorded on a card and the cards are placed inside the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order.Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of the participants, based on the order in which the eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.

Blinding is used to reduce the amount of error in clinical trial studies where the researcher or the group of researchers do not consciously or unconsciously cause errors in the study, for example, it is possible to consciously or unconsciously measure the outcome in the intervention group and the control group with different sensitivity and precision, or in encouraging and following up the patient to comply with the treatment in two groups, they may deal with two different methods. Due to the use of a placebo similar to the interventional treatment, the doctor related to the participants and the participants will not be informed of the treatment assigned, and the analyst will also be unaware of the treatment assigned to the two groups. Finally, after analyzing the data, the researcher who prepared the packages reveals the code A and B. Except for the pharmacist, none of the participants and researchers and analysts will know about the drug or placebo until the end of the study. In this way, the groups are identified only with the code A and B. The drugs are prepared in the same packaging and in the same form and are packaged by a person in the pharmaceutical company who is outside the research, in the form of coded packages A and B. The password of the codes is kept securely in the system so that the codes can be opened after collecting the data.

Protecting patients' privacy