BridgeMD
New treatment option for Fatty Liver
Official title Effect of CoQ10 on the Outcome of MAFLD Patients
ClinicalTrials.gov ID: NCT05984745
What this study is testing
What is Coenzyme Q10 Forte® capsules?
Coenzyme Q10 Forte® capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for fatty liver.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- All study people and prior to consenting to the ICF, laboratory and imaging work-up will be evaluated for the presence of three out of five criteria...
- Waist circumference (WC) ≥ 102/88 cm for men and women respectively.
- HDL cholesterol \<40 mg/dl in men and \<50 mg/dl in women or on specific drug therapy.
- Plasma Triglycerides ≥ 150 mg/dl or on specific drug therapy.
- Blood pressure ≥130 and/or ≥ 85 or on specific anti-hypertensive therapy.
You likely can't join if
- Pregnancy or lactating
- Physical or mental abnormalities
- HCV infection
- HBV infection
- Anaemia
- Thrombocytopenia
See the full eligibility criteria
- All study people 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...
- Waist circumference (WC) ≥ 102/88 cm for men and women respectively.
- HDL cholesterol \<40 mg/dl in men and \<50 mg/dl in women or on specific drug therapy.
- Plasma Triglycerides ≥ 150 mg/dl or on specific drug therapy.
- Blood pressure ≥130 and/or ≥ 85 or on specific anti-hypertensive therapy.
- Fasting blood glucose ≥ 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.