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IRCT20210412050944N2 IRCT 2022-10-10 Qazvin University of Medical Sciences Assessment of the effectiveness of L-carnitine and curcumin in the treatment of non-alcoholic fatty liver Assessment of the effectiveness of L-carnitine and curcumin in the treatment of non-alcoholic fatty liver in patients aged 5 to 15 years old 2022-09-23 anticipated 66 Complete https://irct.ir/trial/64963 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to two treatment groups A and B using the randomized block design method. The randomization unit is individual. The size of each block is 6 and the total number of blocks is 11. The method of balanced randomization allocation for the participants in the randomized controlled clinical trial study of curcumin (group A) and L-carnitine (group B) effect on reducing non-alcoholic fatty liver grade is performed. Allocation concealment is done by central randomization. In this method, a random sequence is available to the researcher, and sampling is done in one center. Based on the order in which the participants entered the study, the researcher communicates with the relevant center and asks about the random allocation of the participants to a specific group. 2 Non-alcoholic fatty liver. Intervention 1: Intervention group 1: For a group of 33 patients, L-carnitine tablets are prescribed at a dose of 50 milligrams per kilogram of body weight in one day (Karen Pharmaceutical Company, Iran). Two L-carnitine tablets, every 12 hours, for 8 weeks daily are given to the patient. All the tests are done before drug administration and three months after drug administration for the patient. The number of educational sessions is four sessions (before prescribing medicine, at the end of the first month, at the end of the second month, and at the end of the third month) for parents. The session's content includes; training on how to take the drug, side effects, beneficial effects, how to treat and the mechanism of action of L-carnitine in the body, and how to evaluate the child's treatment. The duration of training sessions is one hour and the duration of the course is three months. Intervention 2: Intervention group: For a group of 33 patients, Sina curcumin nanomicelle soft gel is prescribed at a dose of 40 milligrams (Exir Nano Sina Pharmaceutical Company, Iran). One Sina curcumin nanomicelle soaftgel, every 24 hours, for 8 weeks on a daily basis are given to the patient. The number of educational sessions is four sessions (before prescribing medicine, at the end of the first month, at the end of the second month, and at the end of the third month) for parents. The content of the session includes; training on how to take the drug, side effects, beneficial effects, how to treat and the mechanism of action of Sina curcumin nanomicelle soaftgel in the body, and how to evaluate the child's treatment. The duration of training sessions is one hour and the duration of the course is three months. Yes - There is a plan to make this available What will be shared: All parts of the Excel file of the participant's data will be provided to the researchers after removing the participants' private information. The study protocol and statistical analysis map can be provided to the researchers by mentioning the reference and the present project as a source. In order to maintain ethical rules, the informed consent form will be provided to the relevant institution and researcher who will use the data of this project. The clinical study report is provided to researchers in the form of a flow diagram. The codes used in the analysis and the data classification system used for the implementation of the new study in line with the continuation of the current project will be available to the researchers as a source and model with references. All the items mentioned will be used during ethical and legal procedures. When: The access period starts 6 months after the results are published To whom: The data will be available to researchers working in academic and non-academic scientific institutions and pharmaceutical companies and can apply to receive them. Conditions: Researchers will send their written request to the project manager, stating reasons and details for access to data and documents. After review by the ethics committee and the research council, if approved, it will be sent. Where to obtain: Researchers will send a written request to executor of the project stating the reasons and details for accessing the data and documentation. How to obtain: The applicant will send his written request to the project manager with reasons and details for access to data and documents. After approval by the project manager, the project manager will send the request to the research assistant. After communicating with the applicant institution or person and providing the necessary explanations to the applicant, the request will be submitted to the university's ethics committee. If approved by the ethics committee, documents and information files will be provided to the applicant. This process takes 6 months. Comments: Without the approval of the ethics committee, the information will not be provided to the applicants.
public Somayeh Janani
Beginning of East Palestine Ave., Shahid Beheshti Blvd., Qazvin Town
Qazvin Iran (Islamic Republic of) 14595-34159 +98 28 3332 8709 somayeh_janani1361@yahoo.com Qazvin University of Medical Sciences scientific Somayeh Janani
Beginning of East Palestine Ave., Shahid Beheshti Blvd., Qazvin Town
Qazvin Iran (Islamic Republic of) 14595-34159 +98 28 3332 8709 somayeh_janani1361@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients who are between 5 to 15 years old. Patients who have increased their liver enzymes more than 40 units per liter. Patients who have been diagnosed with fatty liver in ultrasound. Patients who have been diagnosed with non-alcoholic fatty liver disease by pediatric gastroenterology specialist. Patients who parents consent to participate in this plan. 5 years 15 years Both Patients who suffering from viral hepatitis. Patients who suffering from diabetes. Patients who have taken drugs affecting liver tests in the last 2 months. Patients who suffering from hemochromatosis. Patients who suffering from cirrhosis. Patients who who suffering from addicted to alcohol Patients who suffering from infectious diseases. Patients who suffering from hypothyroidism. Patients who are allergic to curcumin or L-carnitine. Patients who suffering from hypothyroidism. Patients who have not completed the medication for 3 months E88.9 Metabolic disorder, unspecified Treatment - Drugs Treatment - Drugs Intervention group 1: For a group of 33 patients, L-carnitine tablets are prescribed at a dose of 50 milligrams per kilogram of body weight in one day (Karen Pharmaceutical Company, Iran). Two L-carnitine tablets, every 12 hours, for 8 weeks daily are given to the patient. All the tests are done before drug administration and three months after drug administration for the patient. The number of educational sessions is four sessions (before prescribing medicine, at the end of the first month, at the end of the second month, and at the end of the third month) for parents. The session's content includes; training on how to take the drug, side effects, beneficial effects, how to treat and the mechanism of action of L-carnitine in the body, and how to evaluate the child's treatment. The duration of training sessions is one hour and the duration of the course is three months. Intervention group: For a group of 33 patients, Sina curcumin nanomicelle soft gel is prescribed at a dose of 40 milligrams (Exir Nano Sina Pharmaceutical Company, Iran). One Sina curcumin nanomicelle soaftgel, every 24 hours, for 8 weeks on a daily basis are given to the patient. The number of educational sessions is four sessions (before prescribing medicine, at the end of the first month, at the end of the second month, and at the end of the third month) for parents. The content of the session includes; training on how to take the drug, side effects, beneficial effects, how to treat and the mechanism of action of Sina curcumin nanomicelle soaftgel in the body, and how to evaluate the child's treatment. The duration of training sessions is one hour and the duration of the course is three months. Percentage of children with non-alcoholic fatty liver. Timepoint: Before the intervention and 3 months after the administration of L-carnitine and curcumin in the intervention groups. Method of measurement: Ultrasonography and biochemical tests. Qazvin University of Medical Sciences Approved 2022-03-14 Ethics committee of Qazvin University of Medical Sciences Beginning of East Palestine Ave., Shahid Beheshti Blvd., Qazvin Town Qazvin Qazvin Iran (Islamic Republic of)