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IRCT20140301016776N3 IRCT 2021-06-15 Mashhad University of Medical Sciences The effect of Morus nigra extract on patients with liver cirrhosis A randomized, double‐blind, placebo‐controlled trial evaluating the effect of Morus nigra extract on patients with liver cirrhosis 2021-10-23 anticipated 80 Complete https://irct.ir/trial/55663 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to balance the number of patients in the two groups (A and B), the block randomization method will be used. After confirming the inclusion criteria and obtaining consent, patients are randomized by the research assistant based on blocks with size 4 or 6 . According to the sample size of 80 participants, 8 blocks with size 4 from AABB, ABAB, ABBA, BABA, BBAA, BAAB and 8 with size 6 from AAABBB, BBBAAA, BAAABB, BAABBA, BBAAAB, ABBABA, BABBAA, ABBAAB, BBABAA, ........ are selected using a random number table. The sealed envelope will be used for randomization, Blinding description: Packages containing drug and placebo capsules are marked A and B. After randomization of patients by the research assistant, the capsules are provided to the participants by the same assistant. Two groups of participants (intervention patients and control patients) and researchers evaluating patients (serum biochemical factors and liver ultrasound) are not aware of grouping. 2-3 Liver cirrhosis. Intervention 1: Intervention group: In this group, patients will receive capsules containing Morus nigra fruit extract (two 500 mg capsules, three times daily) orally for 12 weeks. Intervention 2: Control group: Subjects in the placebo group will receive capsules containing microcrystalline cellulose (two 500 mg capsules, three times daily) orally for 12 weeks. Yes - There is a plan to make this available What will be shared: Study data including results related to primary and secondary outcomes after statistical analysis can be shared. When: starting 6 months after publication To whom: Available for people working in academic institutions Conditions: Sharing of study data is subject to permission of Mashhad University of Medical Sciences. Where to obtain: Applicants can contact the principle Investigator via email. How to obtain: Sharing of study data is subject to permission of Mashhad University of Medical Sciences. Comments:
public Ahmad Ghorbani
Department of Pharmacology, Faculty of Medicine, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2278 ghorbania@mums.ac.ir Mashhad University of Medical Sciences scientific Ahmad Ghorbani
Department of Pharmacology, Faculty of Medicine,
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2278 ghorbania@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with liver cirrhosis awaiting liver transplantation 18 years 75 years Both Hepatocellular carcinoma or other malignancy History of liver transplantation Alcoholic drink Variceal bleeding Portal vein thrombosis Pregnancy K74 Fibrosis and cirrhosis of liver Treatment - Drugs Treatment - Drugs Intervention group: In this group, patients will receive capsules containing Morus nigra fruit extract (two 500 mg capsules, three times daily) orally for 12 weeks. Control group: Subjects in the placebo group will receive capsules containing microcrystalline cellulose (two 500 mg capsules, three times daily) orally for 12 weeks. MELD index. Timepoint: Before intervention and end of the study. Method of measurement: The MELD index is determined by total bilirubin, serum creatinine, and INR (9.57 Ln(Creat) + 3.78 Ln(bili) + 11.2 Ln(INR) + 6.43). Child-Pugh. Timepoint: before intervention and at the end of study. Method of measurement: This index is calculated based on total bilirubin, albumin, INR, ascites and encephalopathy. Patient survival. Timepoint: One year after enrollment. Method of measurement: Record the number of patient deaths. Liver enzymes. Timepoint: Before intervention and at the end of study. Method of measurement: Fasting blood test. Mashhad University of Medical Sciences Approved 2021-01-27 Ethics committee of Mashhad University of Medical Sciences Qoreyshi building - Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)