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IRCT20230522058260N1 IRCT 2025-03-08 Khoram-Abad University of Medical Sciences Investigating the effect of chitosan supplementation on non-alcoholic fatty liver steatosis patients Investigating the effect of chitosan supplementation on non-alcoholic fatty liver steatosis patients 2025-04-09 anticipated 60 Complete https://irct.ir/trial/79063 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: 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 description: 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. 3 Fatty liver. Intervention 1: Intervention group: People in this group receive capsules containing chitosan, with a dose of 500 mg, 6 pieces per day, 2 pieces half an hour before each main meal (breakfast, lunch, dinner), for 60 days (2 months), along with dietary recommendations according to the grade of the disease. It is recommended that people consume each chitosan capsule with 1 glass of water. Intervention 2: Control group: People in this group receive capsules containing 500 mg of Avicel, six capsules per day, half an hour before each main meal (breakfast, lunch, dinner), for 60 days (2 months), along with dietary recommendations according to the grade of the disease. It is recommended that people take each placebo capsule with 1 glass of water. No - There is not a plan to make this available Justification or reason for not sharing IPD is Protecting patients' privacy
public Dr. Ebrahim Fallahi
Medical Sciences University Campus Complex، 3 km Khorramabad Borujard، Khorramabad، Lorestan
Khorramabad Iran (Islamic Republic of) 6813816314 +98 66 3333 6141 publicrelation@lums.ac.ir Khoram-Abad University of Medical Sciences scientific Dr. Ebrahim Fallahi
Shahid Anoushirvan Rezaei Square، Moalem St، Khorramabad، Lorestan
khorramabad Iran (Islamic Republic of) 6813833946 +98 66 3330 0661 e_falahi@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Age 18 to 65 years Diagnosis of fatty liver grade one and two Filling the informed consent form by the individual Not during pregnancy and breastfeeding. Do not have morbid obesity (body mass index greater than 40 Do not have a history of consuming more than 20 grams of alcohol per day for women and more than 30 grams per day for men. Suffering from any type of immune disorder including: autoimmune disorders, cancer, human immunodeficiency virus (HIV) Do not suffer from liver or kidney failure, other liver diseases such as hepatitis, alcoholic fatty liver. Do not use hepatotoxic drugs such as sodium valproate. Do not have a history of food allergy to marine products and herbal supplements or chitosan. Do not have a history of bariatric surgery to lose weight 18 years 65 years Both Pregnancy and breastfeeding Morbid obesity (body mass index greater than 40) History of alcohol consumption (more than 20 grams per day for women and more than 30 grams per day for men), Having any type of immune disorder, including: autoimmune disorders, cancer, human immunodeficiency virus (HIV) Suffering from liver or kidney failure, other liver diseases such as hepatitis, alcoholic fatty liver Taking hepatotoxic drugs such as sodium valporate History of food allergy to chitosan and herbal supplements History of bariatric surgery for weight loss Hypothyroidism, diabetes, high blood pressure, diet, medications and weight loss supplements K76.0 Nonalcoholic fatty liver disease [NAFLD]،Central haemorrhagic necrosis of liver،Infarction of liver،Hepatorenal syndrome،Chronic passive congestion of liver Treatment - Other Placebo Intervention group: People in this group receive capsules containing chitosan, with a dose of 500 mg, 6 pieces per day, 2 pieces half an hour before each main meal (breakfast, lunch, dinner), for 60 days (2 months), along with dietary recommendations according to the grade of the disease. It is recommended that people consume each chitosan capsule with 1 glass of water. Control group: People in this group receive capsules containing 500 mg of Avicel, six capsules per day, half an hour before each main meal (breakfast, lunch, dinner), for 60 days (2 months), along with dietary recommendations according to the grade of the disease. It is recommended that people take each placebo capsule with 1 glass of water. The amount of hepatic steatosis at the beginning and end of the study is measured by elastography as the primary outcome. Timepoint: The beginning and end of the study. Method of measurement: It is measured by elastography. Status of receiving food. Timepoint: At the beginning, during the study and at the end of the study, it is measured and checked. Method of measurement: Remembered 3 days of food. Khoram-Abad University of Medical Sciences Approved 2024-11-26 Ethics Committee of Lorestan University of Medical Sciences University Blvd، Khorramabad، Lorestan Khorramabad Lorestan Iran (Islamic Republic of)