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IRCT20100420003760N8 IRCT 2024-01-23 Khoram-Abad University of Medical Sciences Investigating the effect of mountain Rosa canina L in the treatment of fatty liver 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) 2024-02-20 anticipated 36 Complete https://irct.ir/trial/75048 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Non-Alcoholic Liver Disease. Intervention 1: Intervention group: receive the first dose (62 mg phytosome) of phytosome formulation containing Rosa Canina L. in addition to conventional treatment. The capsule will be taken orally for 8 weeks, on a 500 mg capsule that contains the compounds tiliroside, catechin and curcumin. The capsules are prepared by Kimia Daru Company. Intervention 2: Intervention group: receive the first dose (125 mg phytosome) of phytosome formulation containing Rosa Canina L. in addition to conventional treatment. The capsule will be taken orally for 8 weeks, on a 500 mg capsule that contains the compounds tiliroside, catechin and curcumin. The capsules are prepared by Kimia Daru Company. Intervention 3: Intervention group: receive the first dose (250 mg phytosome) of phytosome formulation containing Rosa Canina L. in addition to conventional treatment. The capsule will be taken orally for 8 weeks, on a 500 mg capsule that contains the compounds tiliroside, catechin and curcumin. The capsules are prepared by Kimia Daru Company. Intervention 4: Control group: receive placebo (0 mg phytosome) in addition to conventional treatment. The capsule will be taken orally for 8 weeks, on a 500 mg capsule that contains the compounds catechin and curcumin. The capsules are prepared by Kimia Daru Company. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main consequence or similar, can be shared When: Start the access period 18 months after printing the results. To whom: Data will only be available to researchers working at academic and scientific institutions Conditions: The data will only be used to inform the results of the study Where to obtain: Lorestan University of Medical Sciences How to obtain: 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 Comments:
public Marzieh Rashidipour
No. 140, Razi Ave. Pajohandeh Blvd, Herbal Research Center
khorramabad Iran (Islamic Republic of) 6814989468 +98 66 3320 4005 m_rashidi80@yahoo.com Khoram-Abad University of Medical Sciences scientific Marzieh Rashidipour
No. 140, Razi Ave. Pajohandeh Blvd, Herbal Research Center
khorramabad Iran (Islamic Republic of) 6814989468 +98 916 667 4776 m_rashidi80@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Patients with sonographic findings of grade 1 to 3 fatty liver (or if possible based on fibroscan results) 18 years no limit Both Pregnant and lactating women Any finding of cirrhosis Hepatitis Pregnant and lactating women Fatty liver due to secondary causes such as alcohol consumption Taking hypoglycemic drugs Taking lipid-lowering drugs Taking anti-inflammatory drugs and any drugs affecting the liver People with kidney, respiratory, thyroid diseases Having a history of weight loss (more than 5% in the last 6 months) or bariatric surgery Participation in other studies related to clinical trials K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: receive the first dose (62 mg phytosome) of phytosome formulation containing Rosa Canina L. in addition to conventional treatment. The capsule will be taken orally for 8 weeks, on a 500 mg capsule that contains the compounds tiliroside, catechin and curcumin. The capsules are prepared by Kimia Daru Company. Intervention group: receive the first dose (125 mg phytosome) of phytosome formulation containing Rosa Canina L. in addition to conventional treatment. The capsule will be taken orally for 8 weeks, on a 500 mg capsule that contains the compounds tiliroside, catechin and curcumin. The capsules are prepared by Kimia Daru Company. Intervention group: receive the first dose (250 mg phytosome) of phytosome formulation containing Rosa Canina L. in addition to conventional treatment. The capsule will be taken orally for 8 weeks, on a 500 mg capsule that contains the compounds tiliroside, catechin and curcumin. The capsules are prepared by Kimia Daru Company. Control group: receive placebo (0 mg phytosome) in addition to conventional treatment. The capsule will be taken orally for 8 weeks, on a 500 mg capsule that contains the compounds catechin and curcumin. The capsules are prepared by Kimia Daru Company. Fatty liver grade. Timepoint: Before, and after intervention. Fibroscan time 0 and 360. Method of measurement: Through Questionnaire and Fibroscan. Khoram-Abad University of Medical Sciences Approved 2023-10-10 Ethic Committee of Lorestan University of Medical Sciences No 20, Anooshirvan Rezaei Square, Lorestan University of Medical Sciences khorramabad Lorestan Iran (Islamic Republic of)