To evaluate the efficacy of combination of vitamin B and alpha lipoic acid formulations for the treatment of diabetic polyneuropathy in individuals with type 2 diabetes mellitus.
Methodology :
This is a single-center, randomized, double-blind, placebo-controlled trial study.
Study duration May 2024 - September 2025
Study location :
This study will be conducted at the Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia.
Source Reference :
People with type 2 diabetes mellitus attending the Hospital Universiti Sains Malaysia.
Study source population :
People with type 2 diabetes mellitus attended Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia during the study period.
Aged 18 years and over
Diagnosed with type 2 diabetes mellitus based on WHO diagnostic criteria for diabetes (Organization, 2020).
Diagnose with diabetic polyneuropathy by Neurological Symptom Score (NSS) and Neuropathy Disability Score (NDS).
Those with a documented mental impairment which impacted on their ability to answer questions independently.
People with peripheral vascular disease (non-palpable foot pulses, intermittent claudication)
People with an amputated foot or leg
Abnormal liver enzyme.
Universiti Sains Malaysia
Lead sponsor
BREGO Life Sciences Sdn Bhd
Collaborator