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IRCT20250911067210N1 IRCT 2025-09-26 Tehran University of Medical Sciences Studying the effect of herbal syrup on fatty liver TFLS Effects of herbal syrup based on Persian medicine containing turmeric (Curcuma longa), lemon (citrus lemon), pomegranate (Punica granatum) and sumac (Rhus coriaria L) on metabolic status in patients with non-alcoholic fatty liver(NAFLD): A randomized clinical trial 2025-10-23 anticipated 50 Recruiting https://irct.ir/trial/86149 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed using computer-assisted randomization (RAS). The sequence will be in permutation blocks of four, with patients stratified according to gender and fatty liver status. Except for the study pharmacist who will provide the randomization list and sequential numbering of the drug, the other investigators and all patients will not be aware of this list. The sequence of allocation is sealed and concealed by sequential numbering, Blinding description: The principles of blinding are that neither the drug nor the placebo are distinguishable in color, size, odor, shape, weight, or packaging. This blinding will be maintained throughout the study, and only the pharmacist will be aware of the allocation. Randomized, coded allocation boxes were used to conceal the drug and placebo and prevent their identification. The pharmacist will ensure that neither the participants nor the researchers will be aware of the contents of the boxes until the end of the study. 2 Non-alcoholic fatty liver. Intervention 1: Intervention group: The intervention is based on the prescription of a herbal syrup formulation prepared from turmeric, sumac, pomegranate, and lemon. Turmeric and sumac are purchased from the pharmaceutical market and approved by the herbarium and receive a herbarium code. Pomegranate is purchased in the form of pomegranate paste from a specific brand, as well as lemon juice from a specific brand. 20 grams of turmeric root powder and 10 grams of sumac powder are boiled in 500 ml of water for 20-30 minutes, then strained and 20 grams of pomegranate paste and 20 grams of lemon juice are added to it. Stevia, xantham gum, and edible glycerin are used for flavoring and consistency. Intervention 2: Control group: The placebo formulation is made using non-medicinal ingredients such as stevia, xantham gum, edible glycerin, permitted food coloring, and pomegranate essential oil, and a small percentage of lemon juice (5% of the drug). Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identification. When: Access period starts 6 months after results are published. To whom: Researchers working in academic and scientific institutions and people who are also involved in industry Conditions: To improve the process of drug research and production Where to obtain: Vice President for Research, Faculty of Iranian Medicine, Tehran University of Medical Sciences How to obtain: The request is accepted via email and upon approval by the project implementation team. Comments:
public Azadeh Zarei
Palestine Square, beginning of West Taleghani Street, North Sarparast Street, Faculty of Persian Medicine
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8897 6527 drzarei.azadeh@gmail.com Tehran University of Medical Sciences scientific Mehrdad Karimi
Palestine Square, beginning of West Taleghani Street, North Sarparast Street, Faculty of Persian Medicine
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8897 6527 Mehrdadkarimi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Both male and female Patients with grade 2 or 3 NAFLD Age range 20 to 65 years 20 years 65 years Both People with chronic thyroid disorders Autoimmune disorders Types of malignancies Various liver diseases, except non-alcoholic fatty liver disease, including hepatitis (A, B, C) Wilson's disease Crohn's disease Uncontrolled diabetes Hemochromatosis Alcohol users and hepatotoxicants Following other complementary therapies to treat NAFLD Pregnant or breastfeeding women K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: The intervention is based on the prescription of a herbal syrup formulation prepared from turmeric, sumac, pomegranate, and lemon. Turmeric and sumac are purchased from the pharmaceutical market and approved by the herbarium and receive a herbarium code. Pomegranate is purchased in the form of pomegranate paste from a specific brand, as well as lemon juice from a specific brand. 20 grams of turmeric root powder and 10 grams of sumac powder are boiled in 500 ml of water for 20-30 minutes, then strained and 20 grams of pomegranate paste and 20 grams of lemon juice are added to it. Stevia, xantham gum, and edible glycerin are used for flavoring and consistency. Control group: The placebo formulation is made using non-medicinal ingredients such as stevia, xantham gum, edible glycerin, permitted food coloring, and pomegranate essential oil, and a small percentage of lemon juice (5% of the drug). Liver grade change in Fibroscan examination. Timepoint: At the beginning of the study and after eight weeks at the end of the treatment intervention. Method of measurement: Fibroscan device. Changes in liver enzymes. Timepoint: At the beginning of the study and after eight weeks of therapeutic intervention at the end of the study. Method of measurement: Blood test. Tehran University of Medical Sciences Approved 2025-07-29 Ethics committee of Tehran University of Medical Sciences Keshavarz Boulevard - Intersection of Qods Street - Central Building of Tehran University of Medical Sciences - 6th Floor - Room 604 Tehran Tehran Iran (Islamic Republic of)