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

Launched by UNIVERSITI SAINS MALAYSIA · Aug 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a combination of Vitamin B and alpha-lipoic acid on treating diabetic polyneuropathy, a type of nerve damage that can occur in people with type 2 diabetes. The goal is to see if these supplements can help improve symptoms for individuals who are experiencing this condition. The trial will take place at the Klinik Rawatan Keluarga and diabetes clinic at Hospital Universiti Sains Malaysia from May 2024 to September 2025.

To participate, you need to be at least 18 years old and have a diagnosis of type 2 diabetes and diabetic polyneuropathy, which will be assessed using specific scoring systems. However, certain individuals may not be eligible, such as those with mental impairments, serious vascular issues, or those currently taking certain medications that could interfere with the study. If you qualify, you will be randomly assigned to either receive the treatment or a placebo (a treatment with no active ingredients), and neither you nor the researchers will know which one you are receiving. This is to ensure the results are reliable. If you are interested, please reach out to the study team for more details!

Gender

ALL

Eligibility criteria

• 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.