Effects of Hydroalcoholic extract of Cichorium intybus leaves on liver functional indexes in patient with Non Alcholic Fatty liver disease

Effect of hydroalcoholic extract of Cichorium intybus leaves on liver functional indexes in patient with non alcholic fatty liver disease

This clinical trial was performed on 40 patients, divided into two groups of 20, including a control group and parallel groups. This study is blinded and simple randomization is used.

The field of work is clinical - internal. This study is performed in the gastrointestinal clinic of Tohid Hospital in Sanandaj. The intervention group is given a 500 mg capsule of Cichorium intybus leaves daily for two months, along with standard treatment.

Inclusion criteria: subjects over 20 years old who were diagnosed with non alcholic fatty liver disease (NAFLD) by Sonography and increased levels of ALT and AST Exclusion criteria: Alcohol consumption of more than 140cc in men and 70 cc in women per week, Patients with viral hepatitis, diabetes, Patients taking lipid-lowering drugs, Pregnancy and Lactation, Patients taking drugs affecting liver enzymes, Patients with autoimmune diseases, History of bleeding and hemostatic disorders, Patients taking anticoagulants like warfarin, Patients with allergies to herbs and herbal medicines

Intervention group: Cichorium intybus, oral capsule, 500 mg, Once a day for two months with standard treatment Control group: placebo containing starch, oral capsule, 500 mg, Once a day for two months with standard treatment

Alanine Aminotransferase (ALT); Aspartate Aminotransferase (AST); Alkaline Phosphatase (ALP); Bilirubin; Cholestrol; Triglyceride; High Density Lipoprotein (HDL); Low Density Lipoprotein (LDL); Grade of fatty liver; Body Mass Index (BMI)

Using block randomization method with a block size of 4. Sampling method at this study will be according to random allocation. Participants will enter the study according to inclusion criteria, and then will be divided into two groups according to randomization table. One group will receive chicory (Capsule containing Cichorium intybus) and the other will receive placebo. The participants and administrator do not have any information about content of capsules (double blinded study). The list of randomization was computer-generated. supplements and placebo capsules were placed in completely identical packages and were coded by someone who was unaware of the nature of the study in numbered bottles based on the list. And another person who was unaware of the contents of the pack provided them to the patients.

All supplements and placebo capsules were identical with respect to appearance and only differed in coding of the capsules. The treatment code of the intervention supplements was blinded for subjects, investigators and staff involved in the conduct of the study.