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IRCT20110314006065N5 IRCT 2025-03-01 Tehran University of Medical Sciences Acupuncture and Fatty liver The Effects of Acupuncture with Weight Loss Diet on Metabolic Parameters in Patients with Non-Alcoholic Fatty Acid Liver: Randomized Controlled Single-Blinded Clinical Trial 2025-04-05 anticipated 60 Complete https://irct.ir/trial/81898 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to allocate participants to the two study arms (intervention and control groups), simple randomization will be used. This method is designed to ensure a fair and unbiased distribution of participants between the groups and to reduce the impact of confounding factors. After screening and confirming eligibility for the study, a list of qualified participants will be created. Then, using the RAS software, a random sequence for allocating participants to the study groups will be generated. In this method, information regarding the number of groups and sample size is input into the software, which then generates random numbers accordingly. The output is a list equal to the sample size, divided into the two groups. Therefore, the allocation of individuals to one of the two groups will be completely random and unpredictable. Based on this list, it will be determined whether an individual entering the study is placed in the acupuncture group or the control group. The allocation of individuals to one of the two study groups is concealed, and participants are unaware of their assigned group. After generating the random chain in the software, qualified individuals are assigned a code from 1 to 60 based on their entry time into the study. Based on the pre-established sequence and the individual’s code, it will be determined which group they are allocated to, Blinding description: Acupuncture is performed at sites other than the treatment points for fatty liver in the sample group. 3 Non-Alcoholic Fatty Liver Disease (NAFLD). Intervention 1: Intervention group: The participants will receive acupuncture (twice a week) along with a weight loss diet. The individuals involved in this treatment will be monitored by a nutrition specialist. The diets will consist of 50% carbohydrates, 20% protein, and 30% fat, and will have 500 kilocalories subtracted from the total energy requirement calculated for each individual to facilitate weight loss. Additionally, to receive acupuncture, participants will visit the Ahmadieh Health Center, affiliated with Tehran University of Medical Sciences, twice a week. Each session will last 45 minutes and will consider acupuncture points specified for NAFLD (Non-Alcoholic Fatty Liver Disease) in recognized acupuncture resources, conducted by a Chinese medicine specialist. The acupuncture points of interest are as follows: Ren 12, Ren 14, Ren 10, Stomach 36, Liver 3, Liver 2, Stomach 40, Stomach 36, Spleen 9, Stomach 44, Liver 13. Intervention 2: Control group: A group receiving acupuncture (at points other than those for treating fatty liver) along with a weight-loss diet. Participants in this treatment will be supervised by a nutritionist. The diets will consist of 50% carbohydrates, 20% protein, and 30% fat, with a reduction of 500 kilocalories from the total energy requirement calculated for each individual for weight loss. Additionally, sham acupuncture will be used for the purpose of masking the patient. Sham acupuncture will be performed at points other than those for treating non-alcoholic fatty liver, using the same number of needles (11 points). Participants will visit the Ahmadieh Health Center affiliated with Tehran University of Medical Sciences twice a week. Each session will last 45 minutes. No - There is not a plan to make this available Justification or reason for not sharing IPD is confidentiality
public Nazli Namazi
Next to Shariati Hospital, Jalal-e-Al-Ahmad Highway
Tehran Iran (Islamic Republic of) 1411713119 +98 21 8863 1297 nazli.namazi@yahoo.com Tehran University of Medical Sciences scientific Nazli Namazi
Next to Shariati Hospital, Jalal al ahmad highway
Tehran Iran (Islamic Republic of) 1411713119 +98 21 6694 9630 nazli.namazi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with non-alcoholic fatty liver disease (NAFLD) with grades 2 or 3 20 years 65 years Both Individuals with chronic thyroid disorders Autoimmune disorders Various malignancies Liver diseases other than non-alcoholic fatty liver disease, including types of hepatitis (A, B, C) Wilson's disease Crohn's disease Uncontrolled diabetes Hemochromatosis Alcohol consumers and hepatotoxic substances Adherence to traditional treatment methods including the use of herbal medicine for treating NAFLD Pregnant or breastfeeding women K76 Other diseases of liver Treatment - Other Treatment - Other Intervention group: The participants will receive acupuncture (twice a week) along with a weight loss diet. The individuals involved in this treatment will be monitored by a nutrition specialist. The diets will consist of 50% carbohydrates, 20% protein, and 30% fat, and will have 500 kilocalories subtracted from the total energy requirement calculated for each individual to facilitate weight loss. Additionally, to receive acupuncture, participants will visit the Ahmadieh Health Center, affiliated with Tehran University of Medical Sciences, twice a week. Each session will last 45 minutes and will consider acupuncture points specified for NAFLD (Non-Alcoholic Fatty Liver Disease) in recognized acupuncture resources, conducted by a Chinese medicine specialist. The acupuncture points of interest are as follows: Ren 12, Ren 14, Ren 10, Stomach 36, Liver 3, Liver 2, Stomach 40, Stomach 36, Spleen 9, Stomach 44, Liver 13. Control group: A group receiving acupuncture (at points other than those for treating fatty liver) along with a weight-loss diet. Participants in this treatment will be supervised by a nutritionist. The diets will consist of 50% carbohydrates, 20% protein, and 30% fat, with a reduction of 500 kilocalories from the total energy requirement calculated for each individual for weight loss. Additionally, sham acupuncture will be used for the purpose of masking the patient. Sham acupuncture will be performed at points other than those for treating non-alcoholic fatty liver, using the same number of needles (11 points). Participants will visit the Ahmadieh Health Center affiliated with Tehran University of Medical Sciences twice a week. Each session will last 45 minutes. Liver enzymes. Timepoint: Baseline and the end (8th weeks). Method of measurement: Enzymetic. Fasting blood sugar. Timepoint: Baseline and End (8th week). Method of measurement: Enzymatic. Total cholesterol (TC). Timepoint: Baseline and End (8th week). Method of measurement: Enzymatic. Triglyceride (TG). Timepoint: Baseline and End (8th week). Method of measurement: Enzymatic. Low lipoprotein density cholesterol (LDL-C). Timepoint: Baseline and End (8th week). Method of measurement: Enzymatic. High-density lipoprotein cholesterol (HDL-C). Timepoint: Baseline and End (8th week). Method of measurement: Enzymatic. Weight. Timepoint: Baseline and End (8th week). Method of measurement: Scale. Body mass index (BMI). Timepoint: Baseline and End (8th week). Method of measurement: Dividing weight to square of height in meter. Tehran University of Medical Sciences Approved 2025-01-19 Endocrinology and Metabolism research Institude-Tehran University of Medical Sciences Jalal-e-Al-Ahmad Highway-Next to Shariati Hospital, Tehran Tehran Tehran Iran (Islamic Republic of)