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Study aim
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Determination of the efficacy of traditional drug based on Coriandrum sativum on the ultrasound grade and serum level of liver enzymes in patients with non-alcoholic fatty liverse in patients referred to Besat Clinic in Kerman in 1399-1400
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Design
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Clinical trial with control group, with parallel groups, double blind, randomized, phase 3 on 80 patients. The quadruple block method was used for randomization.
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Settings and conduct
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This study is a randomized clinical trial in patients referred to Besat Clinic in Kerman with symptoms of metabolic syndrome. The patients are randomly divided into two groups of drugs and placebo based on the quadruple block method. Due to the similarity of the drug and placebo, patients do not know which group they are in. On the other hand, drug and placebo coding is done by the pharmacist and the researcher is unaware of how patients are assigned to the groups until the end of the study. In both groups, before the start of the study and after the end of the liver ultrasound treatment course, the serum levels of liver enzymes including AST, ALT and ALP are evaluated and compared.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
Non-alcoholic fatty liver based on ultrasound (grades 1 to 3)
Age 18 to 70 years
Informed consent of the patient;
Exclusion criteria:
Pregnancy or breastfeeding
Alcoholic Fatty liver
Smoking
Taking hypoglycemic, hypolipidemic and anti-inflammatory drugs
Other diseases such as viral hepatitis, coronary artery disease, kidney, lung and thyroid diseases
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Intervention groups
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The intervention group is given four 500 mg tablets daily (two in the morning and two at bedtime) of traditional medicine based on coriander, and the control group is given four 500 mg placebo tablets containing starch powder for two months.
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Main outcome variables
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Fatty liver ultrasound grade, serum levels of ALT, AST and Alk-P enzymes