Investigating the effect of chicory root extract on improving the degree of fatty liver in patients with non-alcoholic fatty liver disease: a randomized clinical trial with a double-blind control group

Determining the effect of dried chicory root extract powder on improving the degree of fatty liver in people with non-alcoholic fatty liver disease

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 220 patients. The rand function of Excel software was used for randomization.

Specialized clinics of Sayad and 5 Azar and Deziani hospitals.

Entry requirements: Age 18 to 60 years, male or female, liver grade 2 or 2 to 3 or 3 diagnosed by ultrasound (US) or diagnosis of NAFLD by fibroscan Exit conditions: history of allergy to herbal medicines in the composition, Presence of pregnancy and breastfeeding History of liver problems, including liver cirrhosis. Hereditary liver diseases, such as Wilson's, hemochromatosis and tumoral and parasitic liver diseases, obesity (BMI>35), diabetes and participating in another clinical study of fatty liver in 2 months before entering the present study

220 people with non-alcoholic fatty liver disease, between the ages of 18 and 60 (110 men or women in each group) were referred by internists and gastroenterologists from the specialized clinics of Sayad, 5 Azar, and Deziani hospitals, to the Iranian Medical School. and Traditional Medicine Unit of Deziani Clinic under the Golestan University of Medical Sciences with the inclusion criteria, after obtaining informed consent and filling the clinical information checklist .

Main outcome: Improvement of fatty liver degree during 8 weeks of study Secondary outcome: reduction of aminotransferase levels and lipid profile; fasting sugar; ferritin; total bilirubin and BMI; WHR after week 8 and 12 of the study

The randomization process of the samples is extracted using the simple random method with the envelope method, in which the letters A (intervention group) and B (control group) are written in the envelopes, and according to the letters that come out of the sample envelopes, study groups will be assigned.

So that both the patients and the research doctor related to the patients are unaware of the exposure received by the patient. In other words, both the research doctor and the patients do not know whether they are taking a placebo or a drug.