Capsule production containing Phytosomes carrying standardized Rosa canina L seed extract based on tiliroside separately and in combination with curcumin and catechins in patients with Non-Alcoholic Liver Disease (NAFLD)

Investigating the effect of edible phytosome containing Rosa Canina L. extract on fatty liver grade change

A randomized clinical trial, triple blind, 144 patients enrolled and followed for 8 weeks

Patients diagnosed with fatty liver are randomly divided into oral capsule and placebo groups, patients are evaluated for 8 weeks and fibroscan is recorded in patients at baseline and at the end of 8 weeks. Patients will be evaluated in the gastroenterology and liver specialist office.

Patients with sonographic findings of grade 1 to 3 fatty liver (or if possible based on fibroscan results), not pregnant, not breastfeeding, not taking lipid-lowering drugs, thyroid and hormonal drugs, alcohol, hepatotoxic drugs The criteria for not entering the study include: any findings related to cirrhosis, hepatitis, pregnancy, breastfeeding, fatty liver due to secondary reasons such as alcohol consumption, use of blood sugar and lipid lowering drugs, anti-inflammatory and any drug affecting the liver, people with diseases renal, respiratory, thyroid diseases, having a history of weight loss (more than 5% in the last 6 months) or bariatric surgery, participating in other studies related to clinical trials

Intervention group: receive the first dose (62) of phytosome formulation containing Rosa canina L. extract in addition to conventional treatment Intervention group: receive the second dose (125) of phytosome formulation containing Rosa canina L extract in addition to conventional treatment Intervention group: receive the third dose (250) of phytosome formulation containing Rosa canina L extract in addition to conventional treatment Control group: receive placebo in addition to conventional treatment

Changing the grade of fatty liver based on fibroscan results

Random allocation of patients into four groups and also using stratified random allocation. In this way, classes are made based on age group (below 40 years and older or equal to 40 years), gender (male and female) and severity (mild, moderate or severe). Within each class, random permutation blocks are used to assign samples to the required groups. To create random sequences, letters A, B , C or D(corresponding to the experimental group) will be used as follows. ABCD: 0-3 ABDC: 4-7 ACBD: 8-11 ACDB:12-15 . . DABC DBAC DCAB DCBA: 92-95 Then a corner of the table of random numbers is selected and two-digit numbers are read from top to bottom, and finally, according to the read number, a random sequence of letters A to D is registered in the desired floor. Finally, a random sequence of letters A to D (corresponding to the 4 experimental groups) will be created in each class of all existing classes, and the samples will be assigned to 4 groups based on this random sequence.

A random sequence of letters A to D (corresponding to 4 experimental groups) will be created in each class from all the existing classes, and the samples will be assigned to 4 groups based on this random sequence. This study will be triple blind, which means that the pain intensity disease severity assessor, the patient and the data analyst are not aware of the type of treatment assigned to the patient. In addition, the decipherer is not a member of the research team, and the capsules in all groups are completely identical in appearance. Data registration in the statistical software and data analysis is done by the statistical consultant without mentioning the names of the groups.

Only part of the data, such as information about the main consequence or similar, can be shared

Start the access period 18 months after printing the results.

Data will only be available to researchers working at academic and scientific institutions

The data will only be used to inform the results of the study

Lorestan University of Medical Sciences

Refer to Lorestan University of Medical Sciences, Vice Chancellor of Research and Technology, Research Projects Department, Management of Research Projects Department, 066333120175, Mrs. Sajedi , fax:066333120173 call mrs. zarei 0989167083314