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IRCT20180313039075N1 IRCT 2021-01-03 Shahid Beheshti University of Medical Sciences Evaluation the effects of L Carnitine on quality of life of the cirrhotic patients Evaluation the effects of L Carnitine on quality of life of the cirrhotic patients 2020-12-21 anticipated 120 Complete https://irct.ir/trial/51580 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 120 cirrhotic patients who referred to liver clinic of Taleghani hospital with age 18-70 years old and known cause of cirrhosis with child score A or B and based on inclusion and exclusion criteria will enroll in this study. They will be assigned in three groups with simple randomization. At the end each group will contain 40 patients, Blinding description: Random assigning will be done by one of our research team and patients, medical doctor and statistician are blind in this study. 3 Liver cirrhosis. Intervention 1: Intervention group 1: 1000 mg L Carnitine by Zist Takhmir company will use daily for 24 weeks. Intervention 2: Intervention group 2: 2000 mg L Carnitine by Zist Takhmir company will use daily for 24 weeks. Intervention 3: Control group: Placebo by Zist Takhmir company will use daily for 24 weeks. Yes - There is a plan to make this available What will be shared: data sharing at end of the study When: At end of the study To whom: researchers Conditions: for other researches Where to obtain: Research institute for Gastroenterology and Liver Diseases of SBMU How to obtain: contact with this study researchers Comments:

public Leila Pasharavesh

Velenjak

Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2521 l.pasharavesh@gmail.com Shahid Beheshti University of Medical Sciences scientific Behzad Hatami MD

Velenjak

Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2243 9982 bzd_hatami@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Cirrhotic patients who referred to Liver clinic of Taleghani hospital with age 18-70 years old Cirrhotic patients who referred to Liver clinic of Taleghani hospital with known case of cirrhosis Cirrhotic patients who referred to Liver clinic of Taleghani hospital with Child score A or B Cirrhotic patients who referred to Liver clinic of Taleghani hospital with no administration of L-Carnitine before 18 years 70 years Both Not tolerate use of L-Carnitine because of the gastrointestinal problem Gastrointestinal bleeding Uncontrolled malignant tumors Need of hemodialysis Pregnancy Receiving drugs causing hyperammonemia Overt hepatic encephalopathy Patients who do not accept to continue the study Patients with other significant background diseases (heart failure, chronic kidney disease,…) K70, K74 Cirrhosis of the liver Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: 1000 mg L Carnitine by Zist Takhmir company will use daily for 24 weeks Intervention group 2: 2000 mg L Carnitine by Zist Takhmir company will use daily for 24 weeks Control group: Placebo by Zist Takhmir company will use daily for 24 weeks Quality of life. Timepoint: First, 3 months later, 6 months later. Method of measurement: Standard questionnaire for quality life in cirrhotic patients. Sarcopenia. Timepoint: First, 3 months later, 6 months later. Method of measurement: Evaluate gripe strength by dynamometer and muscle mass by bioelectrical impedance analysis (BIA). Zist takhmir company Approved 2020-12-09 Ethics committee of research institute for gastroenterology and hepatology Arabi st., Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)