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IRCT20100524004010N34 IRCT 2022-07-08 Shahid Beheshti University of Medical Sciences The effects of caffeine supplementation on clinical parameters and disease severity in patients with hepatic cirrhosis The effects of caffeine supplementation on clinical parameters and disease severity in patients with hepatic cirrhosis 2022-07-03 anticipated 25 Complete https://irct.ir/trial/63881 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, participants were classified into two groups with normal (18.5-24.9) and overweight (24.9-29.9) by stratified blocked randomization method and based on BMI and randomly assigned to One of the groups caffeine consumption or placebo consumption group. Separate randomization is done based on BMI within each group. The size of the blocks is 4, with two assignments to the intervention group (A) and two allocations to the control group (B). There are 6 different permutations of AABB, ABAB, BBAA, BABA, ABBA, BAAB, Blinding description: Patients won’t know if they are receiving the caffeine or a placebo for double-blinding the study, the bottles containing the relevant soft gels will be concealed as A and B by a third person at the beginning of the study, and none of the research team members will know the type of soft gels received by each group. 2-3 Hepatic Cirrhosis. Intervention 1: Intervention group: Will take 400 mg of caffeine daily in the form of two tablets each contains 200 mg of caffeine (Product of raha Company) orally for eight weeks. Intervention 2: Control group: Will take two placebo tablets daily, which are similar in shape and taste to caffeine tablets, orally for eight weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We have not yet decided how to share the final data.
public Azita Hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azita Hekmatdoost
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Having desire to participate in the study Age range of 18-75 BMI between 18.5 to 30 kg per square meter Do not develop extrahepatic organ failure Do not take caffeinated drugs for one month before the start of the study Do not consume more than 3 cups of coffee per day Not pregnant or breastfeeding 18 years 75 years Both The patient's unwillingness to continue cooperation Patients who have consumed less than 80% of the capsules. The diagnosis of the treating physician at the end of the patient's participation in the study Pregnancy or breastfeeding Loss of more than 10% of body weight during the study period Other Placebo Intervention group: Will take 400 mg of caffeine daily in the form of two tablets each contains 200 mg of caffeine (Product of raha Company) orally for eight weeks. Control group: Will take two placebo tablets daily, which are similar in shape and taste to caffeine tablets, orally for eight weeks. Model for end-stage liver cirrhosis score (MELD score). Timepoint: At the beginning and the end of the study. Method of measurement: Using the formula. Serum total billirubin. Timepoint: At the beginning and the end of the study. Method of measurement: Enzymatic method. Serum albumin. Timepoint: At the beginning and the end of the study. Method of measurement: Enzymatic method. Serum Alanine transaminase (ALT). Timepoint: At the beginning and the end of the study. Method of measurement: Enzymatic method. Serum Aspartate aminotransferase (AST). Timepoint: At the beginning and the end of the study. Method of measurement: Enzymatic method. Serum creatinine. Timepoint: At the beginning and the end of the study. Method of measurement: Enzymatic method. Serum Na. Timepoint: At the beginning and the end of the study. Method of measurement: Enzymatic method. Serum Alkaline phosphate (ALP). Timepoint: At the beginning and the end of the study. Method of measurement: Enzymatic method. International normalized ratio (INR). Timepoint: At the beginning and the end of the study. Method of measurement: Calculate the ratio. Prothrombin time (PT). Timepoint: At the beginning and the end of the study. Method of measurement: Prothrombin time measurement. Partial thromboplastin time (PTT). Timepoint: At the beginning and the end of the study. Method of measurement: Partial Thromboplastin Time measurement. Serum platelets. Timepoint: At the beginning and the end of the study. Method of measurement: Automatic cell count. Tumor necrosis factor-alpha (TNF-a). Timepoint: At the beginning and the end of the study. Method of measurement: ELISA method. Interleukin 6 (IL-6). Timepoint: At the beginning and the end of the study. Method of measurement: ELISA method. Serum c-reactive protein (CRP). Timepoint: At the beginning and the end of the study. Method of measurement: ELISA method. Child pugh score. Timepoint: At the beginning and the end of the study. Method of measurement: Using the formula. Fibrosis 4 score. Timepoint: At the beginning and the end of the study. Method of measurement: Using the formula. AST to platelets ratio index (APRI). Timepoint: At the beginning and the end of the study. Method of measurement: Calculate the ratio. Shahid Beheshti University of Medical Sciences Approved 2022-05-24 Ethics Committee of the National Institute of Nutritional Research and Food Industry No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehrab Tehran Iran (Islamic Republic of)