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IRCT20191130045548N1 IRCT 2020-07-28 Mashhad University of Medical Sciences Evaluation of therapeutic effects of a pomegranate preparation in patients with hepatic cirrhosis Evaluation of therapeutic effects of a Panica granatum preparation in patients with hepatic cirrhosis using a randomized clinical trial 2020-09-22 anticipated 70 Complete https://irct.ir/trial/43825 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization is as block randomization and randomization unit is block (4-units block). The randomization tool and random sequence generation are done using random number table and through http://www.randomization.com. We have two groups in our study (indicated as A and B letters). Therefore, for random blocks, 6 modes of moving them are possible and the below formula is used. Also, the method of allocation concealment is equentially numbered, sealed, opaque envelopes. 6 modes=2.4*3=![2-4]*[(2*1)!2]/(4*3*2*1*)!4, Blinding description: The blinding is as double in this study. For proper blinding, the drug (in our study, the herbal preparation from pomegranate) and placebo will be exactly the same in color, size, and odor, and other than the pharmacist, none of the participants and researchers will be aware of them until the end of the study. 2 liver cirrhosis. Intervention 1: Intervention group: In this group, an herbal preparation of pomegranate at 20 mg/kg body weight, is orally given twice in a day for 2 months to the patients with liver cirrhosis. This study is done as double blind with 70 patients who randomly assigned in two groups (35 patients in each) and other than the pharmacist, none of the participants and researchers will be aware of the administrated drug and placebo until the end of the study. Therefore, 35 patients with cirrhosis is given the drug, randomly. A number of blood tests including AST, ALT, ALP, Albumin, creatinine, bilirubin, international normalized ratio for pro thrombintime (INR), for MELD factor (Model for End-Stage Liver Disease) calculation as well as also clinical investigations for presence of ascites and hepatic encephalopathy are done before and after the intervention for this intervention group. Intervention 2: Control group: In this group, a preparation without pomegranate (placebo) which is exactly the same in color, size, and odor with the drug is orally given twice in a day for 2 months to the patients with liver cirrhosis. This study is done as double blind with 70 patients who randomly assigned in two groups (35 patients in each) and other than the pharmacist, none of the participants and researchers will be aware of the administrated drug and placebo until the end of the study. Therefore, 35 patients with cirrhosis is given the placebo, randomly. A number of blood tests including AST, ALT, ALP, Albumin, creatinine, bilirubin, international normalized ratio for pro thrombintime (INR), for MELD factor (Model for End-Stage Liver Disease) calculation as well as also clinical investigations for presence of ascites and hepatic encephalopathy are done before and after the intervention for this intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Arezoo Rajabian
Vakilabad st., Faculty of Medicine, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 9177948564 0098 38828265 rajabianar@mums.ac.ir Mashhad University of Medical Sciences scientific Arezoo Rajabian
Vakilabad st., Faculty of Medicine, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 8265 rajabianar@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with hepatic cirrhosis 18 years 70 years Both Non-cirrhotic patients Cirrhotic patients who have progressed to liver transplantation K74.69 Other cirrhosis of liver Treatment - Drugs Placebo Intervention group: In this group, an herbal preparation of pomegranate at 20 mg/kg body weight, is orally given twice in a day for 2 months to the patients with liver cirrhosis. This study is done as double blind with 70 patients who randomly assigned in two groups (35 patients in each) and other than the pharmacist, none of the participants and researchers will be aware of the administrated drug and placebo until the end of the study. Therefore, 35 patients with cirrhosis is given the drug, randomly. A number of blood tests including AST, ALT, ALP, Albumin, creatinine, bilirubin, international normalized ratio for pro thrombintime (INR), for MELD factor (Model for End-Stage Liver Disease) calculation as well as also clinical investigations for presence of ascites and hepatic encephalopathy are done before and after the intervention for this intervention group. Control group: In this group, a preparation without pomegranate (placebo) which is exactly the same in color, size, and odor with the drug is orally given twice in a day for 2 months to the patients with liver cirrhosis. This study is done as double blind with 70 patients who randomly assigned in two groups (35 patients in each) and other than the pharmacist, none of the participants and researchers will be aware of the administrated drug and placebo until the end of the study. Therefore, 35 patients with cirrhosis is given the placebo, randomly. A number of blood tests including AST, ALT, ALP, Albumin, creatinine, bilirubin, international normalized ratio for pro thrombintime (INR), for MELD factor (Model for End-Stage Liver Disease) calculation as well as also clinical investigations for presence of ascites and hepatic encephalopathy are done before and after the intervention for this intervention group Model for End-Stage Liver Disease (MELD) score. Timepoint: The beginning of the study (or before administration of pomegranate preparation) and two months after (two months after administration of the preparation). Method of measurement: ALT (Alanin Transaminase), AST (Aspartate Aminotransferase), ALP ( Alkaline Phosphatase), INR ( International Normalized Ratio), Albumin, creatinine, bilirubin, also clinical investigations for presence of ascites and hepatic encephalopathy and calculation of MELD score Model for End-Stage Liver Disease. Mashhad University of Medical Sciences Approved 2020-06-28 Ethics committee of Mashhad University of Medical Sciences Vakilabad Blvd., ŮŽAzadi St., Mashhad Town Mashhad Razavi Khorasan Iran (Islamic Republic of)