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IRCT20210524051376N1 IRCT 2021-06-30 Babol University of Medical Sciences The effect of herbal product from Berberis integerrima on Non-Alcoholic Fatty Liver Disease The effect of herbal product from Berberis integerrima on ultrasound image echogenicity of patients with Non-Alcoholic Fatty Liver Disease 2021-05-31 anticipated 60 Complete https://irct.ir/trial/56436 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling is done as an easy sampling and allocation of the drug with a quadruple block randomization pattern Two types of herbal and classical medicines were prepared by the researcher in identical shapes, sizes and colors, and then they were mediated by a person who had nothing to do with this research. Encoded in closed-form packages and enclosed to research samples based on the list of random numbers created by the person above. The code list is kept secret and kept until the data analysis, the end of the study day, is kept confidential. Randomized study codes are opened when statistical tests are performed, Blinding description: Two types of herbal and classical medicines were prepared by the researcher in identical shapes, sizes and colors, and then to hide the allocation and to ensure that they did not know what type of drug they used, they were mediated by a person who had nothing to do with this research. Encoded in closed-form packages and enclosed to research samples based on the list of random numbers created by the person above. The code list is kept secret and kept until the data analysis, the end of the study day, is kept confidential. Randomized study codes are opened when statistical tests are performed. 3 Fatty liver. Intervention 1: Intervention group: herbal syrup from Berberis integerrima (75mg /mL) 2 cups (10ml) per day for three months after breakfast and dinner and return to the same centers for ultrasound and testing. Diets with the aim of reducing daily fat intake and eliminating unhealthy fast foods and carbonated beverages are given to both groups in exactly the same way based on available clinical guidelines. Patients are monitored monthly and their changes in weight (BMI) and blood pressure are recorded, and they are also asked to submit their diet three consecutive days each month. Intervention 2: Control group: Placebo contains simple syrup with 2.5% of the studied extract 2 cups (10ml) a day for three months after breakfast and dinner and go to the same centers again for ultrasound and testing. Diets with the aim of reducing daily fat intake and eliminating unhealthy fast foods and carbonated beverages are given to both groups in exactly the same way based on available clinical guidelines. Patients are monitored monthly and their changes in weight (BMI) and blood pressure are recorded, and they are also asked to submit their diet three consecutive days each month. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Narjes Gorji
Ganjafrooz st.
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 9592 n.gorji@mubabol.ac.ir Babol University of Medical Sciences scientific Narjes Gorji
Ganjafrooz st.
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 9592 n.gorji@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Increased liver echogenicity (grade 2 non-alcoholic fatty liver) based on ultrasonographic findings 20 years 60 years Both The underlying illness (Diabetes mellitus, cardiovascular diseases, liver disease (cirrhosis, alcoholic liver disease, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, biliary obstruction, hepatic damage induced by hereditary hemochromatosis drugs, sclerosis cholangitis and α deficiency of an antitrypsin), other serious diseases such as cancer; kidney failure and celiac disease Pregnancy Lactation Drug history with increase hepatic steatosis risk (Tamoxifen, valproate sodium, ... Antihyperlipidemic drugs Malnutrition special diets such as vegetarianism and raw eating Alcohol consumption Smoking and addiction Acute psychiatric disorder K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: herbal syrup from Berberis integerrima (75mg /mL) 2 cups (10ml) per day for three months after breakfast and dinner and return to the same centers for ultrasound and testing. Diets with the aim of reducing daily fat intake and eliminating unhealthy fast foods and carbonated beverages are given to both groups in exactly the same way based on available clinical guidelines. Patients are monitored monthly and their changes in weight (BMI) and blood pressure are recorded, and they are also asked to submit their diet three consecutive days each month. Control group: Placebo contains simple syrup with 2.5% of the studied extract 2 cups (10ml) a day for three months after breakfast and dinner and go to the same centers again for ultrasound and testing. Diets with the aim of reducing daily fat intake and eliminating unhealthy fast foods and carbonated beverages are given to both groups in exactly the same way based on available clinical guidelines. Patients are monitored monthly and their changes in weight (BMI) and blood pressure are recorded, and they are also asked to submit their diet three consecutive days each month. The ultrasound image echogenicity of patients with Non-Alcoholic Fatty Liver Disease. Timepoint: 3 months after the start of the intervention. Method of measurement: Ultrasonography grading and lab test (TG, LDL,HDL, AST ,ALT). Body wheight. Timepoint: 3 months after the start of the intervention. Method of measurement: Measure weight (kg). Babol University of Medical Sciences Approved 2019-08-18 Babol university of medical science Ganjafrooz st. Babol, Mazandaran, Iran Babol Mazandaran Iran (Islamic Republic of)