Evaluation of therapeutic effects of a Panica granatum preparation in patients with hepatic cirrhosis using a randomized clinical trial

Determination of effect of a pomegranate preparation in patients with liver cirrhosis

Clinical trial with control group, with parallel group, double blind, randomized

This study is in the field of herbal medicnes. In a clinical trial, an herbal preparation of pomegranate was administered to 70 patients with liver cirrhosis in Ghaem hospital, Mashhad University of Medical Sciences. The patients were randomly divided to two groups (35 in each). A group will be given the pomegranate preparation and the other group is given the placebo. In this double blind trial, Participants, clinicians and evaluators will be unaware of intervention and control groups. 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.

Patients with liver cirrhosis (Hepatic cirrhosis)

In Intervention group, a herbal preparation of pomegranate in patients with liver cirrhosis is given. In control group, a preparation without pomegranate (placebo) is given

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

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

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.

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