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IRCT20260623069924N1 IRCT 2026-07-11 Arak University of Medical Sciences "Effects of a Syrup Containing Chicory Extract and Vitamin E in Patients with Non Alcoholic Fatty Liver Disease" Evaluation of the Efficacy and Safety of a Syrup Containing Processed Chicory (Cichorium intybus) Extract and Vitamin E on Disease Severity in Patients with Non Alcoholic Fatty Liver Disease: A Randomized, Double Blind, Placebo Controlled Clinical Trial 2026-09-06 anticipated 106 Recruiting https://irct.ir/trial/91103 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To ensure balanced distribution of variables such as age, sex, disease severity, and lifestyle factors between the intervention and placebo groups, block randomization will be used. Randomization will be performed using blocks of four participants with six possible allocation sequences (AABB, ABAB, BAAB, ABBA, BABA, and BBAA), where A represents the intervention group and B represents the placebo group. The random allocation sequence will be generated using the RAND function in Microsoft Excel. The unit of randomization will be the individual participant, Blinding description: This study will be conducted as a double blind trial. Participants and the investigator will be unaware of treatment allocation. The intervention product and placebo will be identical in appearance, color, odor, taste, volume, and packaging. Study products will be labeled and coded according to the randomization list by a pharmacist or an independent person not involved in participant assessment. Treatment allocation codes will remain confidential until study completion. Participants will be assigned to study groups based on the randomization code on the package. The investigator, participants, laboratory expert, and outcome assessor will remain blinded to group allocation throughout the study. Unblinding will be permitted only after completion of data collection and analysis or in the event of a medical emergency. 3 Nonalcoholic Fatty Liver Disease (NAFLD). Intervention 1: Intervention group: Participants with Grade 2 Non Alcoholic Fatty Liver Disease will receive a syrup containing 4 g of processed hydro alcoholic powdered extract of chicory (Cichorium intybus) and 13.5 mg of vitamin E per 100 mL of syrup. The prescribed dose is three tablespoons (approximately 15 g) daily for 3 months. Intervention 2: Control group: Participants in the placebo group will receive a placebo syrup packaged in containers identical to those used for the intervention product. The placebo consists of an aqueous solution containing a small amount of chicory flavored essence and is identical to the intervention product in terms of appearance, color, odor, taste, volume, and packaging. It will be administered at the same dose and according to the same dosing schedule as the intervention group, that is, three tablespoons daily for 3 months. Yes - There is a plan to make this available What will be shared: De-identified individual participant data including demographic characteristics (age, sex), anthropometric measurements (BMI, waist circumference), blood pressure, laboratory parameters (ALT, AST, triglycerides, total cholesterol, LDL-C, HDL-C, platelet count), and FibroScan results (CAP score and liver stiffness measurement) collected at baseline and after 3 months of intervention. When: The data will be available from the time of publication of the primary study results and will remain accessible for 5 years after publication. To whom: Applicants must submit a formal request to the Principal Investigator of the study. Following review and approval of the request by the research team, and in compliance with participant confidentiality and data protection requirements, the requested data will be made available through encrypted electronic files. Conditions: The study data will be available for scientific research, educational purposes, and secondary analyses. Applicants must submit a formal request to the principal investigator. Access will be granted after review and approval by the research team and subject to protection of participant confidentiality through de identification of data. Data may be used only for the approved scientific purposes and in accordance with research ethics requirements. Where to obtain: Applicants must submit a formal request to the Principal Investigator of the study. Following review and approval of the request by the research team, and in compliance with participant confidentiality and data protection requirements, the requested data will be made available through encrypted electronic files. How to obtain: Applicants must submit a formal request to the Principal Investigator of the study. Following review and approval of the request by the research team, and in compliance with participant confidentiality and data protection requirements, the requested data will be made available through encrypted electronic files. Comments:
public Nafiseh Noormohammadi feyjani
Vice Chancellor for Research and Technology, Payambar-e-Azam University Campus, Arak University of Medical Sciences, Basij Square, Sardasht Boulevard, Arak, Iran
Arak Iran (Islamic Republic of) 3848176341 +98 86 3422 2128 noor_5754@yahoo.com Arak University of Medical Sciences scientific Nafiseh Noormohammadi feyjani
Vice Chancellor for Research and Technology, Payambar-e-Azam University Campus, Arak University of Medical Sciences, Basij Square, Sardasht Boulevard, Arak, Iran
Arak Iran (Islamic Republic of) 3848176341 009843222128 noor_5754@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Total cholesterol level greater than or equal to 240 mg/dL. Triglyceride level greater than or equal to 500 mg/dL Low density lipoprotein cholesterol level greater than or equal to 130 mg/dL High density lipoprotein cholesterol level greater than or equal to 40 mg/dL. Alanine aminotransferase level greater than or equal to 35 U/L Aspartate aminotransferase level greater than or equal to 35 U/L Fibro Scan findings demonstrating liver stiffness within the moderate fibrosis range (7 to 9.5 kPa) and Controlled Attenuation Parameter (CAP) greater than 290 dB/m.. Age between 20 and 60 Years Non pregnant women Willingness to participate in the study and provision of written informed consent Known No allergy to chicory or its components No concurrent use of other herbal medicines besides the prescribed study treatment No alcohol consumption 20 years 60 years Both Participant's decision to receive alternative treatments during the study period Occurrence of allergic reactions or treatment related adverse events K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Participants with Grade 2 Non Alcoholic Fatty Liver Disease will receive a syrup containing 4 g of processed hydro alcoholic powdered extract of chicory (Cichorium intybus) and 13.5 mg of vitamin E per 100 mL of syrup. The prescribed dose is three tablespoons (approximately 15 g) daily for 3 months. Control group: Participants in the placebo group will receive a placebo syrup packaged in containers identical to those used for the intervention product. The placebo consists of an aqueous solution containing a small amount of chicory flavored essence and is identical to the intervention product in terms of appearance, color, odor, taste, volume, and packaging. It will be administered at the same dose and according to the same dosing schedule as the intervention group, that is, three tablespoons daily for 3 months. Serum Alanine Aminotransferase (ALT) Level. Timepoint: Before and after the 3-month intervention. Method of measurement: Serum alanine aminotransferase level measured using standard laboratory methods. Serum alanine aminotransferase level measured using standard laboratory methods. Timepoint: methods before and after the 3-month intervention. Method of measurement: Measured in venous blood samples using an automated biochemical analyzer. U/L. Serum aspartate aminotransferase level measured using standard laboratory. Timepoint: methods before and after the 3-month intervention. Method of measurement: Measured in venous blood samples using an automated biochemical analyzer.U/L. Serum triglyceride concentration measured by enzymatic laboratory methods at baseline and after intervention. Timepoint: methods before and after the 3-month intervention. Method of measurement: Measured in fasting serum samples using enzymatic colorimetric methods.mg/dL. Serum total cholesterol concentration measured using standard biochemical assays. Timepoint: methods before and after the 3-month intervention. Method of measurement: Measured in fasting serum samples using enzymatic colorimetric methods.mg/dL. Serum total cholesterol concentration measured using standard biochemical assays. Timepoint: methods before and after the 3-month intervention. Method of measurement: Measured in fasting serum samples using enzymatic colorimetric methods.mg/dL. Serum low-density lipoprotein cholesterol level measured. Timepoint: methods before and after the 3-month intervention. Method of measurement: Measured in fasting serum samples using an automated biochemical analyzer.mg/dL. Serum high-density lipoprotein cholesterol level measured at baseline. Timepoint: methods before and after the 3-month intervention. Method of measurement: Measured in fasting serum samples using an automated biochemical analyzer.mg/dL. Body mass index calculated. Timepoint: methods before and after the 3-month intervention. Method of measurement: weight in kilograms divided by height in meters/kg/m². Adverse events. Timepoint: methods before and after the 3-month intervention. Method of measurement: Number and type of adverse events reported by participants or observed by investigators during the 3-month intervention period with chicory product or placebo. Liver Stiffness). Timepoint: methods before and after the 3-month intervention. Method of measurement: Fibro Scan. Peripheral blood platelet. Timepoint: methods before and after the 3-month intervention. Method of measurement: measured using an automated hematology analyzer.×10³/µL. Arak University of Medical Sciences Approved 2026-05-10 Ethics committee of Arak University of Medical Sciences Vice Chancellor for Research and Technology, Payambar-e-Azam University Campus, Arak University of Medical Sciences, Basij Square, Sardasht Boulevard, Arak, Iran Arak Markazi Iran (Islamic Republic of)