The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient

Summary

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.

Eligibility

Inclusion Criteria:

1. Aged 18 years and over
2. Diagnosed with type 2 diabetes mellitus based on WHO diagnostic criteria for diabetes (Organization, 2020).
3. Diagnose with diabetic polyneuropathy by Neurological Symptom Score (NSS) and Neuropathy Disability Score (NDS).

Exclusion Criteria:

1. Those with a documented mental impairment which impacted on their ability to answer questions independently.
2. People with peripheral vascular disease (non-palpable foot pulses, intermittent claudication)
3. People with an amputated foot or leg
4. Abnormal liver enzyme.
5. People with renal impairment.
6. People using drugs with possible influence on the study results (antidepressants, anticonvulsants, opiates, neuroleptics, antioxidants, and particularly methylcobalamin, pyridoxine and other B complex preparations)
7. Pregnancy, lactation, or childbearing age without safe contraception
8. History of allergy with vitamin B complex preparations (i.e. Vitamin B12, B6 and B1) and alpha lipoic acid.

Conditions2

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