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Effect of CoQ10 on the Outcome of MAFLD Patients

RecruitingPhase 2Ages 18 Years - 80 YearsAllAin Shams University
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In plain words

What the trial is, and whether it could suit you

So far there has been no universal treatment for MAFLD since it has a complex etiology that involves ethnic, genetic, metabolic and environmental factors. However, therapeutic life changes including: diet, weight loss, and physical activity remain the cornerstone of treatment and is recommended by both American and European associations. Inflammatory biomarkers, such as tumor necrosis factor-alpha, and adipokines play key roles in the pathogenesis of MAFLD, hence, the anti-inflammatory and antioxidant effects of coenzyme Q10 especially at high doses that have not been tested are hypothesized to have a beneficial role in improving the systemic inflammation and biochemical variables. This study is conducted to test this hypothesis

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: All study subjects and prior to consenting to the ICF, laboratory and imaging work-up will be evaluated for the presence of three out of five criteria for metabolic dysregulation in the context of metabolic -dysfunction associated fatty liver disease (MAFLD): 1. Waist circumference (WC) โ‰ฅ 102/88 cm for men and women respectively. 2. HDL cholesterol \<40 mg/dl in men and \<50 mg/dl in women or on specific drug therapy. 3. Plasma Triglycerides โ‰ฅ 150 mg/dl or on specific drug therapy. 4. Blood pressure โ‰ฅ130 and/or โ‰ฅ 85 or on specific anti-hypertensive therapy. 5. Fasting blood glucose โ‰ฅ 100 mg/dl or on specific anti hyperglycemic therapy * Patients who agree to sign an informed consent * Adult patients \>18 years old. * Males and females * Willing to comply with procedures and follow up * Elevated serum transaminases (1-4 times the ULN) * Imaging evidence of fatty liver: pelviabdominal ultrasound and Fibro- CAP study Exclusion Criteria: * Pregnancy or lactating * Physical or mental abnormalities * HCV infection * HBV infection * Anaemia * Thrombocytopenia * Haematological malignancies * Ongoing alcoholism (Male: \>30g/day, Female: \>20g/day) * Patients with renal failure * Autoimmune hepatitis * Celiac disease * Wilson's disease * Hemochromatosis * Drugs: Tamoxifen, Valproic acid, Amiodarone, Methotrexate, Steroids, Anticoagulants, All anti-oxidative stress agents, Cos, IUD * Chronic use of systematically immunosuppressive agent or drugs that can affect liver profile. * Hypo/Hyper-thyroidism * Bypass surgeries * TPN (Total Parenteral Nutrition)
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What it tests

  • Coenzyme Q10 Forteยฎ capsules
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Where

1 site
National Hepatology and tropical medicine research institute
Cairo, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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