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A Polyherbal Compound for Patients with Non-alcoholic Fatty Liver Disease: A Single Blinded Randomized Clinical Trial

Publish Year: 1399
Type: Conference paper
Language: English
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MSEMSMED14_087

Index date: 14 November 2021

A Polyherbal Compound for Patients with Non-alcoholic Fatty Liver Disease: A Single Blinded Randomized Clinical Trial abstract

Background and Objective: Non-alcoholic fatty liver disease (NAFLD) is the most common hepatic disorder with a prevalence of 6-35% worldwide. If NAFLD is not managed at early stages, it progresses to non-alcoholic steatohepatitis, cirrhosis and hepatocellular carcinoma. Up to now, no ideal therapeutic drug has been proven for NAFLD yet. A combination of herbal agents might be more effective when each herb acts through different mechanisms and shows synergistic effect. This study aimed to evaluate the benefits of a polyherbal compound for patients with NAFLD. Materials and Methods: In this double-blind randomized controlled trial, five plants with potent antioxidant, anti-inflammatory, and hypolipidemic effects were choosen. The powders of Anethum graveolens, Citrus bigardia, Cynara scolymus, Portulaca oleracea, and Silybum marianum were mixed together equally and prepared as capsules containing 400 mg of the mixture. The participants of study were derived in convenience method from the Internal Medicine Clinic, Imam-Reza Hospital in Mashhad in 2016-2019. Patients were included in the trial if they had grade ≥ 2 of NAFLD on sonography or had grade 1 of NAFLD with elevated ALT level (>40U/L). Patients were excluded if they had the following criteria: alcohol intake, cancer, pregnancy, severe infection, renal insufficiency, uncontrolled diabetes, and other forms of liver diseases. Sixty patients with NAFLD were randomly divided two groups (2:1ratio): treatment (n=40) and control (n=20). Both groups were advised to take healthy diet and exercise. The treatment group also received the herbal compound for two months (2capsules, three times daily). Data were analyzed using IBM SPSS statistics 20 software and using paired-sample t-test, independent-sample t-test, and Wilcoxon and Mann-Whitney tests. P-value less than 0.05 was considered statistically significant. The Ethics Committee of Mashhad University of Medical Sciences approved the study protocol (number: IR.MUMS.fm.REC.1394.114).Findings: Of the 60 participants randomized, 46 completed the study (16 control and 30 treatment group). The ratio of female to male was 38/62 in the control group and 50/50 in the treatment group. The mean age of patients was 44±8 and 49±11 years in the control and treatment groups, respectively. Before starting study, there was no significant difference in the severity of NAFLD between the two group (P=0.740). Treatment with the polyherbal compound significantly improved the grade of fatty liver (P<0.001), but no significant change was found in the control group (P=0.334). Taking polyherbal compound was associated with significant reductions in the ALT, AST and total cholesterol levels (P<0.05), but no significant changes were found in the control group. In addition, no significant changes were observed in the levels of LDL, HDL and triglyceride in neither of the groups (P<0.05). Conclusion: The formulated polyherbal compound appears to be effective in improving the biochemical and decreasing the grade of fatty liver in patients with NAFLD.

A Polyherbal Compound for Patients with Non-alcoholic Fatty Liver Disease: A Single Blinded Randomized Clinical Trial Keywords:

A Polyherbal Compound for Patients with Non-alcoholic Fatty Liver Disease: A Single Blinded Randomized Clinical Trial authors

Seyyed Abbas Zojaji

Department of pharmacology, Mashhad Branch, Islamic Azad University, Mashhad, Iran

Hooman Mosannen Mozaffari

Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

Pouya Ghaderi

Student Research Committee, Faculty of Medicine, Mashhad Islamic Azad University, Mashhad, Iran.

Faegheh Zojaji

Department of Anesthesiology, School of Medicine, Birjand University of Medical Sciences, Birjand, Iran

Mousa Al-Reza Hadjzadeh

Department of Physiology, Mashhad University of Medical Sciences, Mashhad, Iran

Monireh Seyfimoqadam

Student Research Committee, Faculty of Medicine, Mashhad Islamic Azad University, Mashhad, Iran.