The effect of herbal product from Berberis integerrima on ultrasound image echogenicity of patients with Non-Alcoholic Fatty Liver Disease

The effect of herbal product from Berberis integerrima on ultrasound image echogenicity of patients with Non-Alcoholic Fatty Liver Disease

Two arm parallel group randomized trial double blinded clinical trial (III), 60 patients The method of randomization in this study is quadruple blocking method and the randomization unit is individual and tool is statistical software

After reviewing the inclusion and exclusion criteria and receiving informed consent for participating, the patients Will be divided to two group are provided and asked to consume 2 spoon syrup daily after breakfast and dinner for three months and then ultrasound and lab tests will be repeated.

Inclusion criteria: Patients aged 20 to 60 years with increased hepatic echogenicity (grade 2 non-alcoholic fatty liver) based on ultrasonographic findings Exclusion criteria: Type 2 DM; cardiovascular disease, liver disease; other serious diseases such as cancer; kidney failure and celiac disease, etc .; pregnancy; lactation, taking drugs that cause and stimulate liver steatosis; taking any type of lipid-lowering drugs and fibrates; existence of malnutrition; adherence to special diets such as vegetarianism and raw eating; Alcohol, cigarettes and drugs, acute or underlying psychiatric disorders Drop out criteria: Tendency to leave the plan, do not take medication for a week, drug allergy, occurrence of pregnancy, Non-compliance with dietary instructions more than 30%.

The control group: placebo syrup contained simple syrup with 2.5% of the studied extract Intervention group: Barberry-based herbal syrup (75mg/ml), 2 spoon (10ml) per day

Treatment protocol, degree of fatty liver, AST, ALT, age, sex

Sampling is done as an easy sampling and allocation of the drug with a quadruple block randomization pattern Two types of herbal and classical medicines were prepared by the researcher in identical shapes, sizes and colors, and then they were mediated by a person who had nothing to do with this research. Encoded in closed-form packages and enclosed to research samples based on the list of random numbers created by the person above. The code list is kept secret and kept until the data analysis, the end of the study day, is kept confidential. Randomized study codes are opened when statistical tests are performed.

Two types of herbal and classical medicines were prepared by the researcher in identical shapes, sizes and colors, and then to hide the allocation and to ensure that they did not know what type of drug they used, they were mediated by a person who had nothing to do with this research. Encoded in closed-form packages and enclosed to research samples based on the list of random numbers created by the person above. The code list is kept secret and kept until the data analysis, the end of the study day, is kept confidential. Randomized study codes are opened when statistical tests are performed.