Safety and Efficacy of the Combination Therapy of Fucoidan / Fucoxanthin / L-carnitine in Patients With Diabetic Nephropathy.

Safety and Efficacy of the Combination Therapy of Fucoidan / Fucoxanthin / L-carnitine in Patients With Diabetic Nephropathy.

The purpose of this open-label, preliminary, proof-of-concept clinical trial is to evaluate the efficacy and safety of The purpose of this open-label, preliminary, proof-of-concept clinical trial is to evaluate the efficacy and safety of The purpose of this open-label, preliminary, proof-of-concept clinical trial is to evaluate the efficacy and safety of fucoidan/fucoxanthin/L-carnitine combinaed therapy in patients with diabetic kidney disease.

Participants were randomly assigned in a 1:1 ratio to either the Treatment Group or the Control Group. The primary objective is to investigate whether fucoidan/fucoxanthin/L-carnitine/Zinc yeast combinaed therapy can significantly improve albuminuria or renal function after a treatment period of 12 weeks. Secondary outcomes include evaluating the safety profile and potential side effects of the intervention.

It is hypothesized that the intervention will show a beneficial effect on albuminuria compared to the control group. in patients withdiabetic kidney disease.

Inclusion Criteria:

• Documented glycated hemoglobin (HbA1c) > 6.5% with current use of anti-diabetic medication.
• A urine albumin-to-creatinine ratio (UACR) greater than 30 mcg/mg.

Exclusion Criteria:

• Age younger than 20 years.
• Inability to understand or provide written informed consent.
• Absence of regular treatment for diabetes mellitus.
• Medication non-compliance, defined as completing less than 50% of the prescribed formula (FFL) treatment.
• Newly diagnosed glomerulonephritis during the study period.
• Loss to follow-up, defined as failure to complete all laboratory tests required for outcome assessment.