Status:
UNKNOWN
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
Lead Sponsor:
Kazakh Association of Internal Medicine Specialists
Conditions:
Metabolic-associated Fatty Liver Disease (MAFLD)
Eligibility:
All Genders
18-75 years
Brief 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-assoc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 8 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 8 2025
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT06078722
Start Date
February 8 2023
End Date
February 8 2025
Last Update
October 12 2023
Active Locations (7)
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1
State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"
Esik, Almaty Region, Kazakhstan
2
LLP "InkarMed"
Aktobe, Kazakhstan
3
hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"
Almaty, Kazakhstan
4
Medical Center "iClinic"
Astana, Kazakhstan