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
NCT ID: NCT06078722
Last Updated: 2023-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
264 participants
OBSERVATIONAL
2023-02-08
2025-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study Cohort
Patients taking Carnitine-Orotate Complex and BDD regardless of study participation. The duration of observation for taking COCs and BDD is 6 months, and the duration of follow-up is 6 months.
No interventions assigned to this group
Control cohort
Patients who do not take Carnitine-Orotate Complex and BDD, regardless of study participation. Duration of patient observation - 12 months.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Kazakh Association of Internal Medicine Specialists
OTHER
Responsible Party
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Locations
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State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"
Esik, Almaty Region, Kazakhstan
LLP "InkarMed"
Aktobe, , Kazakhstan
hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"
Almaty, , Kazakhstan
Medical Center "iClinic"
Astana, , Kazakhstan
Non-profit joint-stock company "Semey Medical University"
Semey, , Kazakhstan
Medical center "Gatromed"
Shymkent, , Kazakhstan
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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Erkin Sartaev
Role: primary
Other Identifiers
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KAIMS-01
Identifier Type: -
Identifier Source: org_study_id
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