The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient
The Effectiveness of Fixed Dose Combination of Alpha Lipoic Acid and Vitamin B Preparations for Treatment of Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patients: A Randomized Placebo-controlled Trial
Universiti Sains Malaysia
76 participants
May 27, 2024
INTERVENTIONAL
Conditions
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 Criteria3
- 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 Criteria8
- 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.
Interventions
BIONERV® s the first combination of alpha lipoic acid 300mg and vitamin B complex. Bionerv® is in oral film-coated, orange colour, oblong shape and no marking and embossing on the tablet. Each tablet contains 4 active ingredients as follows: Alpha lipoic acid 300mg, Vitamin B12 (methylcobalamin) 500mcg, Vitamin B6 (pyridoxine) 8mg, Vitamin B1 (thiamine) 39mg. To be taken after meal 1 tablet once daily.
Locations(1)
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NCT06568185