Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing

What Was Tested

In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12).

Diabetic symmetrical polyneuropathy (DSPN) is a common complication of diabetes that affects the nerves, especially in the legs and feet.

It can cause pain, numbness, tingling, weakness, and loss of sensation.

These problems can affect daily activities and quality of life.

It had two arms (groups): Bionerv E+ (experimental) and Vitamin B-Complex (active comparator).

The registry classes the interventions as dietary supplement.

More on the Plan

Diabetic symmetrical polyneuropathy (DSPN) is a common chronic complication of diabetes mellitus.

It is characterized by symmetrical, length-dependent damage to peripheral nerves and may cause pain, burning sensations, numbness, tingling, weakness, and loss of protective sensation.

Vitamins B1, B6, and B12 have roles in normal nerve function and have also been used in the management of neuropathy.

This is a single-centre open label study being conducted at the Hospital Canselor Tuanku Muhriz (HCTM) Orthopaedic Clinic.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged 18 years and above. Diagnosed with Type 2 Diabetes Mellitus. Symptoms of DSPN attributed by diabetes mellitus using Toronto Clinical Neuropathy Scoring (TCNS). No recent changes of medications for DSPN for the last 3 months. Neuropathy Impairment Score (NIS) for lower limbs ≥ 2 points.

The full record lists 16 inclusion and 1 exclusion criteria; among the exclusions: 1\. previous consumption of vitamin e and other antioxidants, taking anti-inflammatory agents for the past 3 months.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the participants and staff both knew the treatment.

It started in 2025-07-22 with completion listed for 2027-01-30.

It ran at 1 site in Malaysia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Neuropathy Impairment Score-Lower Limb (NIS-LL) (time frame: Baseline and Week 13). Change in Neuropathic Pain Assessed by the Short Form McGill Pain Questionnaire (SF-MPQ) (time frame: Baseline and Week 13). Change in Health-Related Quality of Life Assessed by the Short Form-36 (SF-36) (time frame: Baseline and Week 13).

It also tracked 3 secondary outcomes, for example Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP) Levels, Change in Serum Tumor Necrosis Factor-Alpha (TNF-alpha) Levels and Change in Diabetic Foot Ulcer Wound Area.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 100 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.