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.
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).
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.
Parallel
Alpha-Lipoic Acid/Vitamin/Mineral Supplement PolyMVA
DrugBIONERV® 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.
To compare the mean change in Total symptom score (TSS) over 12 a week period
Total Symptom Score is the sum of 4 neuropathic symptoms (stabbing pain, burning pain, paraesthesia, and numbness) reported as symptoms frequency (occasionally, frequent, or continuous) and symptom intensity (absent, slight, moderate, or severe) on which scores range from 0 to 14.64.
To compare the mean change in Neuropathic symptoms score (NSS) over 12 a week period
Neurological Symptom Score consists of 4 components. The first component is on reported discomfort symptoms: burning/numbness/tingling (2 points), fatigue/cramping and aching feelings (1point) and 0 point for none. Second component is on symptom location whether the symptom occurs in the feet (2 points), calves (1 point) and 0 points for elsewhere. The third component is on timing of symptoms, either nocturnal exacerbation (2 points), symptoms present both day and night (1 point) and 0 for symptoms present during daytime only. A score of 1 was added if the symptoms had ever woken the patient from sleep. The fourth component is on a manoeuvre to reduce the symptoms by either walking (2 points) or standing (1pointand and 0 for sitting or lying down. The maximum symptom score was 9.
compare the changes in the fasting plasma glucose over 12 a week period
A fasting blood glucose test measures the amount of glucose in blood after a period of fasting (usually 8-12 hours). Fasting plasma glucose will be measure in millimoles per liter (mmol/L). The participants fasts overnight, usually for 8 hours before the test.
compare the changes in the fasting lipid profile over 12 a week period
A fasting lipid profile (or lipid panel) measures the levels of various types of fats in the blood, including Total Cholesterol, High-Density Lipoprotein (HDL) Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol and triglycerides. Fasting lipid profile will be measure in millimoles per liter (mmol/L). Patients are usually advised to fast overnight, avoiding food and drinks (except water) for 8 hours before the test.
compare the changes in the HbAIC level over 12 a week period
The HbA1c test reflects the average blood glucose levels by measuring the percentage of glycated hemoglobin (hemoglobin bound with glucose) and is an important indicator of long-term blood sugar control. The HbA1c results are reported as a percentage (%) of glycated hemoglobin. The target HbA1C level for most diabetic individuals is typically below 7% to reduce the risk of diabetes-related complications.
compare the changes in blood pressure over 12 a week period
A blood pressure cuff is placed around the upper arm and inflated. The cuff then deflates while measuring the pressure in the arteries. The measurement is taken with an electronic sphygmomanometer. Blood pressure is measured in millimeters of mercury (mmHg). Normal Blood Pressure is systolic less than 120 mmHg and diastolic less than 80 mmHg.
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Universiti Sains Malaysia
Lead sponsor
BREGO Life Sciences Sdn Bhd
Collaborator
