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

Last updated: October 3, 2023
Sponsor: Kazakh Association of Internal Medicine Specialists
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT06078722
KAIMS-01
  • Ages 18-75
  • All Genders

Study Summary

The goal of this observational study is to learn the effectiveness and safety of the use of Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate in the pathogenetic therapy of metabolic-associated fatty liver disease (MAFLD)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of both sexes aged 18 to 75 years, who are citizens of the Republic ofKazakhstan;
  • Patients with a clinically and laboratory confirmed diagnosis of MAFLD, without severeconcomitant diseases;
  • Patients who do not receive other adjuvant therapy (metabolic therapy drugs, essentialphospholipids, ursodeoxycholic acid, glycyrrhizic acid, ademetionine and others);
  • Patients who have at least a 7-day gap between the end of other adjuvant therapy andthe start of COC and BDD;
  • Patients who voluntarily signed the informed consent form.

Exclusion

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 aclinically significant increase in alpha-fetoprotein more than >5 times;
  • patients with pronounced biochemical activity (ALT, AST more than 10 ULN) and totalbilirubin more than 2 ULN;
  • Participation in an interventional clinical trial.

Study Design

Total Participants: 264
Study Start date:
February 08, 2023
Estimated Completion Date:
February 08, 2025

Connect with a study center

  • State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"

    Esik, Almaty Region
    Kazakhstan

    Active - Recruiting

  • LLP "InkarMed"

    Aktobe,
    Kazakhstan

    Active - Recruiting

  • hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"

    Almaty,
    Kazakhstan

    Active - Recruiting

  • Medical Center "iClinic"

    Astana,
    Kazakhstan

    Active - Recruiting

  • Non-profit joint-stock company "Semey Medical University"

    Semey,
    Kazakhstan

    Active - Recruiting

  • Medical center "Gatromed"

    Shymkent,
    Kazakhstan

    Active - Recruiting

  • State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Department of Public Health of the Turkestan region

    Turkestan,
    Kazakhstan

    Active - Recruiting

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