]>
IRCT20220529055009N1 IRCT 2023-02-05 Tehran University of Medical Sciences The Effect of Rivandi Syrup on Non-Alcoholic Fatty Liver To Evaluate the Efficacy of Rivandi Syrup on Non-Alcoholic Fatty Liver Patients 2022-08-06 anticipated 50 Complete https://irct.ir/trial/63966 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, a block of 4 (A-B-C-D) is created, and bottles of drugs or placebos have one of these four labels. In it, there are two letters of drug and two letters of placebo (for example, A and D for drug and B and C for placebo). According to the order of the patients' referral to the plan and after obtaining written consent, the patient will be placed in one of the 4 groups randomly (lottery), and after 4 patients enter the RCT and the end of the 4-pack, another 4-pack will be opened for the 5th to 8th patients. can be Medicines labeled A to D are delivered to Salamat Kedeh pharmacy and the patient receives the medicine with that label after drawing a lottery and getting the letter A, B, C, or D, Blinding description: Bottles of drugs with labels A to D are made by the pharmacist and delivered to the Salamat Kode pharmacy, which two labels are drug and two are placebos, and the pharmacist only knows the contents of each bottle. Patients receives that label and until the end of the RCT (3 Months), it is delivered to him with all the initial labels. 3 Non Alcoholic Fatty Liver. Intervention 1: Intervention group: rhubarb syrup is prepared in the pharmacy laboratory of the Faculty of Traditional Medicine of Tehran University of Medical Sciences (Jalinian medicine) with the combination of Chinese rhubarb, Fumitory and Dodder, whose herbarium code is obtained from the Faculty of Pharmacy of the university, and in 250 bottles CC is provided to patients. Consuming it as one tablespoon three times a day (breakfast, before lunch and before bed). Intervention 2: Control group: Placebo syrup is prepared in the pharmaceutical laboratory of the Faculty of Traditional Medicine of Tehran University of Medical Sciences and is available to patients in 250 cc bottles. Consuming it as one tablespoon three times a day (before breakfast, before lunch and before bed). 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 N/A
public Hossein Rezaeizadeh
No27- North Sarparast St- Felestin Sq
Tehran Iran (Islamic Republic of) 2188974535 +98 21 8897 4535 rezaeizadeh@sina.tums.ac.ir Tehran University of Medical Sciences scientific Hossein Rezaeizadeh
No27- North Sarparast- Felestin Sq
Tehran Iran (Islamic Republic of) 2188974535 +98 21 8897 4535 rezaeizadeh@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Non Alcoholic Fatty Liver Patients 20 years 60 years Both Diabetes, Hypertension, Familial Hyper Lipedema, Chronic Heart Disease Alcohol Use Pregnancy, Lactation K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: rhubarb syrup is prepared in the pharmacy laboratory of the Faculty of Traditional Medicine of Tehran University of Medical Sciences (Jalinian medicine) with the combination of Chinese rhubarb, Fumitory and Dodder, whose herbarium code is obtained from the Faculty of Pharmacy of the university, and in 250 bottles CC is provided to patients. Consuming it as one tablespoon three times a day (breakfast, before lunch and before bed) Control group: Placebo syrup is prepared in the pharmaceutical laboratory of the Faculty of Traditional Medicine of Tehran University of Medical Sciences and is available to patients in 250 cc bottles. Consuming it as one tablespoon three times a day (before breakfast, before lunch and before bed) CAP (Controlled Attenuation Parameter) Index in Fibroscan. Timepoint: 0 and 3 Months. Method of measurement: Fibroscan Device. LSM (Liver Stiffness Measurement) in Fibroscan. Timepoint: 0 and 3 Months. Method of measurement: Fibroscan Device. Blood Serum Aspartate Transferase (AST). Timepoint: 0 and 3th months. Method of measurement: Blood Test. Blood Test Alanine aminotransferase (ALT). Timepoint: 0 and 3th months. Method of measurement: Laboratory Blood Test. Blood Test Alkaline phosphatase (ALP). Timepoint: 0 and 3th months. Method of measurement: Laboratory Blood Test. Body Mass Index (BMI)= ratio of person's weight in kilograms and height in metres squared. Timepoint: 0 and 3th months. Method of measurement: Standard Scale. Tehran University of Medical Sciences Approved 2022-05-23 Ethics committee of Tehran University of Medical Sciences (TUMS) 6th Floor- Central building of TUMS- Qods St- Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)