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IRCT20200628047940N2 IRCT 2022-06-14 Shiraz University of Medical Sciences L-carnitine supplement in end-stage liver disease adult patients To survey the effect of L-carnitine supplement on frailty index in liver cirrhotic adult patients and compare to control group: A double-blind randomized control trial 2022-01-30 anticipated 70 Complete https://irct.ir/trial/61310 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: There is no spesific information, Randomization description: Patients with liver cirrhosis who refer to the inpatient clinic of Abu Ali Sina Transplant Hospital, are examined by a gastroenterologist. If they have inclusion criteria and are willing to participate in the study, they are referred to a medical student to record patient information and measure the frailty index. Patients go to the pharmacy to receive medicine. The patients are divided into the intervention and control groups according to the order of referral, using the supplemental block list by a physician in charge of the pharmacy. The intervention group will receive L-carnitine from the pharmacy according to the list. Randomization method: Permutation block design or quadruple blocks will be used. We assign different permutations to numbers 1 to 6 in the following order. 1. AABB 2. ABAB 3. ABBA 4. BBAA 5. BABA 6. BAAB Then, using the table of random numbers, we extract the numbers from the table and depending on which one of the numbers 1 to 6 comes, select each of the blocks assigned to these numbers until 19 blocks of 4 are selected. If the numbers are zero, 7, 8, and 9, we will ignore them and continue this order to provide a complete list for the entire sample size, Blinding description: The medical students and a gastroenterologist will examine the patient and evaluate the laboratory tests, and frailty index under blinded conditions. The data analyzer is also unaware of case and control groups. N/A liver cirrhosis. Intervention 1: The intervention group receives the L-carnitine supplement (b-hydroxy-gN-trimethylamino-butyric acid), an essential nutrient in the diet. The main function of L-carnitine in cellular energy metabolism, and as an essential element in the transfer of long-chain fatty acids to the inner mitochondrial membrane and the site of beta oxidation. The dose of L-carnitine 500 mg capsule orally three times a day for two months will be given to the patient along with the conventional medication regimen. British Life Plan manufacturer, importer of Nikan Pharmed Mehr Company. Intervention 2: Among patients who have the inclusion criteria and are willing to participate in the study, 35 patients are considered as a control group according to the block list. They will receive conventional medication regimens from pharmacies. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Nasrin Motazedian
Seventh floor, Transplant Research Center, Mohammad Rasulallah Research Tower, Mollasadra St., Khalili Ave., Shiraz, IR Iran
Shiraz Iran (Islamic Republic of) 7193635899 +98 71 3628 1529 motazediann@yahoo.com Shiraz University of Medical Sciences scientific Nasrin Motazedian
Shiraz Transplant Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7193711351 0098716281529 motazediann@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Adult patients(18-50 years old) Cirrhotic patients 18 years 50 years Both Overt hepatic encephalopathy Consumption of L-carnitine supplement in the last year Hepatocellular carcinoma Decompensated cirrhosis MELD more than 20 HbA1c more than7 K74.60 - A K74- Fibrosis and cirrhosis of liver › 2022 ICD-10-CM Diagnosis Code K74.69. Other Rehabilitation The intervention group receives the L-carnitine supplement (b-hydroxy-gN-trimethylamino-butyric acid), an essential nutrient in the diet. The main function of L-carnitine in cellular energy metabolism, and as an essential element in the transfer of long-chain fatty acids to the inner mitochondrial membrane and the site of beta oxidation. The dose of L-carnitine 500 mg capsule orally three times a day for two months will be given to the patient along with the conventional medication regimen. British Life Plan manufacturer, importer of Nikan Pharmed Mehr Company Among patients who have the inclusion criteria and are willing to participate in the study, 35 patients are considered as a control group according to the block list. They will receive conventional medication regimens from pharmacies. ّFraility. Timepoint: before intervention, after 2 months. Method of measurement: Liver frailty index. The liver frailty index will be used in the evaluation of frailty in patients with cirrhosis. This criterion consists of three parts. The Frilati Liver Index consists of three performance-based tests (grip strength, chair stands, and balance), a tool that measures physical function specifically in patients with cirrhosis. Hepatic encephalopathy. Timepoint: Before intervention and 2, months after intervention. Method of measurement: Clinical examination, and lab data. Creatinine level. Timepoint: before intervention, and 2 months after intervention. Method of measurement: lab data. Shiraz Transplant Research Center Approved 2022-01-05 Ethics committee of Shiraz University of Medical Sciences Ethics Commitee, Shiraz University of Medical Sciences, Zand Street, Beside Helal Ahmar, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)