The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient
Recruiting · NCT06568185 · Interventional (participants receive a specific treatment) · Lead sponsor: Universiti Sains Malaysia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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).
Exclusion criteria
- 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.
- People with renal impairment.
- People using drugs with possible influence on the study results (antidepressants, anticonvulsants, opiates, neuroleptics, antioxidants, and particularly methylcobalamin, pyridoxine and other B complex preparations)
- Pregnancy, lactation, or childbearing age without safe contraception
- History of allergy with vitamin B complex preparations (i.e. Vitamin B12, B6 and B1) and alpha lipoic acid.
Where it is running
1 location listed.
- Hospital Universiti Sains Malaysia - Kubang Kerian, Kelantan, Malaysia