RecruitingPhase 2NCT06568185

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


Sponsor

Universiti Sains Malaysia

Enrollment

76 participants

Start Date

May 27, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combination of alpha-lipoic acid (an antioxidant) and vitamin B supplements can reduce nerve pain and damage in people with type 2 diabetes who have diabetic polyneuropathy — a condition where high blood sugar damages the nerves, causing pain, numbness, or weakness, usually in the hands and feet. **You may be eligible if:** - You are 18 or older - You have been diagnosed with type 2 diabetes - You have been diagnosed with diabetic polyneuropathy based on standard nerve symptom scores **You may NOT be eligible if:** - You have a mental impairment affecting your ability to answer questions independently - You have peripheral vascular disease (poor circulation in your feet/legs) - You have had a foot or leg amputation - You have abnormal liver enzymes or kidney problems - You are currently using medications that may affect the study results (like antidepressants, anticonvulsants, opioids, or B-vitamin supplements) - You are pregnant, breastfeeding, or of childbearing age without safe contraception - You are allergic to vitamin B complex or alpha-lipoic acid Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlpha-Lipoic Acid/Vitamin/Mineral Supplement PolyMVA

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)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

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NCT06568185


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