Evaluation of the Effectiveness of the Use of a Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate in the Pathogenetic Therapy of Metabolic-associated Fatty Liver Disease: a Prospective Cohort Study

Launched by KAZAKH ASSOCIATION OF INTERNAL MEDICINE SPECIALISTS · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of two specific treatments—Carnitine-Orotate Complex (COC) and Biphenyl Dimethyl Dicarboxylate (BDD)—for people with metabolic-associated fatty liver disease (MAFLD). The aim is to see if these treatments can help improve liver health in patients diagnosed with this condition. The study is currently recruiting participants between the ages of 18 and 75 who live in Kazakhstan and have been confirmed to have MAFLD, as long as they do not have other serious health issues or are taking certain medications.

If you or someone you know is interested in participating, you should not have a history of heavy alcohol use, diabetes, or other specific health conditions. Participants will need to sign an informed consent form and will be monitored for how well the treatments work and if they are safe to use. This study provides an opportunity to contribute to important research that could help improve treatments for fatty liver disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients of both sexes aged 18 to 75 years, who are citizens of the Republic of Kazakhstan;
• • Patients with a clinically and laboratory confirmed diagnosis of MAFLD, without severe concomitant diseases;
• • Patients who do not receive other adjuvant therapy (metabolic therapy drugs, essential phospholipids, ursodeoxycholic acid, glycyrrhizic acid, ademetionine and others);
• • Patients who have at least a 7-day gap between the end of other adjuvant therapy and the start of COC and BDD;
• • Patients who voluntarily signed the informed consent form.
• Exclusion Criteria:
• • Patients who abuse alcohol according to the AUDIT-c questionnaire;
• • Patients taking COC for more than 4 weeks before signing the informed consent;
• • Patients with contraindications to COC;
• • Patients diagnosed with diabetes mellitus;
• • Pregnancy and lactation;
• • Simultaneous use of levodopa, altretamine, cisplatin, statins;
• • Patients with coinfection with HIV, HBV, HCV;
• • Decompensated liver cirrhosis CPT≥7 points;
• • GFR ≤ 15 ml/min/1.73 m2;
• • Drug-induced liver damage;
• • Taking narcotic and psychotropic drugs;
• • Malignant formations of the liver and other organs (in history and currently) or a clinically significant increase in alpha-fetoprotein more than \>5 times;
• • patients with pronounced biochemical activity (ALT, AST more than 10 ULN) and total bilirubin more than 2 ULN;
• • Participation in an interventional clinical trial.