Diabetic PolyneuropathyPhase 2NCT06568185
The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient
A Phase 2 study testing Alpha-Lipoic Acid/Vitamin/Mineral Supplement PolyMVA in people with Diabetic Polyneuropathy, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- Alpha-Lipoic Acid/Vitamin/Mineral Supplement PolyMVA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteMalaysia
- Study dates
- 27 May 2024to 1 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
Che Nur Ain Che Abdullah, Dr., +60199216023, chenurain@student.usm.my
Noraini Mohamad, Dr., +60139855968, mnoraini@usm.my
About this study
Official title: 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
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 :
Read more
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.
Read the detailed description
General objective
To determine the effectiveness of a fixed dose combination of alpha lipoic acid and vitamin B preparations in comparison with incative drug for treatment of diabetic polyneuropathy (DPN) in people with type 2 diabetes mellitus.
Research hypothesis
- There are significant improvements in mean total symptom score (TSS) and neuropathic symptoms score (NSS) in people with diabetic polyneuropathy taking a fixed dose combination of alpha lipoic acid and vitamin B preparations as compared to diabetic polyneuropathy patients taking a placebo.
- There are significant improvements in total symptom score (TSS) and neuropathic symptoms score (NSS) among people with diabetic polyneuropathy taking a fixed dose combination of alpha lipoic acid and vitamin B preparations for 12 weeks.
- There are significant improvements in fasting plasma glucose, HbA1C level, fasting lipid profile, body mass index (BMI), and diabetes quality of life in people with diabetes taking a fixed dose combination of alpha lipoic acid and vitamin B preparations as compared to diabetic patients taking placebo.
- There are no significant differences in the safety parameters of renal function and liver function tests among people with diabetic polyneuropathy at baseline and 12 weeks after taking a fixed dose combination of alpha lipoic acid and vitamin B preparations.
- There are significant improvements in fasting plasma glucose, HbA1C level, fasting lipid profile, body mass index (BMI), and diabetes quality of life among diabetic patients taking a fixed dose combination of alpha lipoic acid and vitamin B preparations for 12 weeks.
Method of data collection
This study will be conducted after obtaining approval from the Universiti Sains Malaysia Ethical Committee (JPeM) and will be conducted in accordance to World Medical Association Declaration of Helsinki ethical principles for medical research involving human subjects.
Recruitment of subject
Participants will be recruited from Klinik Rawatan Keluarga and diabetes clinic Hospital USM via convenience sampling. Potential participants will be identified from the case notes of patients. Then, the participants will be approached individually. Those who are willing to participate in this study will be given information regarding the study. The participants will be screened to determine their eligibility criteria, including performing neurological symptom score (NSS) and neuropathy disability score (NDS) to determine diabetes polyneuropathy diagnosis. If all the inclusion and exclusion criteria are fulfilled, informed consent will be obtained from all patients who agree to participate in this study. The consent will be obtained by a study team that recruited the patient. Upon consented, the participant's socio-demographic data will be collected, and the medical record will be assessed to fill in their medical and diabetes profiles. They will also answer the total symptoms score (TSS), and revised version of the Diabetes Quality of Life (Rv-DQoL) questionnaire. The physical examination includes measurement of height, weight, calculated Body Mass Index (BMI), and blood pressure during sitting will be done. Then 6ml of fasting venous blood will be taken for measurement of HbA1c, fasting blood glucose, renal function test, liver function test and fasting lipid profile as baseline. All participants were advised not to consume any special supplement or other replacement meal throughout the study.
The participants then will be randomized to either intervention or control group. The intervention group will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations, and the control group will receive a placebo (look-alike substance that contains no drug).
The participants will be seen 6 weeks after taking the product. During this visit, they will be assessed for any side effects or adverse events and compliance with the product supplied (compliance form). The total symptoms score (TSS), neurological symptom score (NSS), a revised version of Diabetes Quality of Life (Rv-DQoL), blood pressure, weight, height, calculated Body Mass Index (BMI) will also be measured. Another 6-week supply of the product will be given.
Lastly, the participants will be assessed in week 12. During this visit, the same measurement will be taken as visit 1, including answering the questionnaires. Adverse events, blood taking, and compliance will also be assessed.
The duration for visit 1 and visit 3 (at 12 weeks) is about 50-60 minutes for each visit since it will involve blood taking procedure. Duration for visit 2 (at 6 weeks) is about 30 minutes since it will not involve blood taking.
Intervention group: Fixed dose combination of alpha lipoic acid and vitamin B preparations
At baseline, the intervention group will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations. This product is packaged and manufactured by BREGO Life Sciences Sdn Bhd company with a brand name of Bionerv®. BIONERV® is 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. All the above ingredients are synthetic. The shelf-life is 2 years. Storage condition is keeping in dry place below 300oC and protecting from light and moisture. It has no bovine-gelatin capsule. There are no precautions on drug-drug interaction, but it is not suitable for children (<18 years). There is insufficient reliable data for pregnancy and breast feeding. One bottle consists of 60 tablets.
This medication needs to take 2 tablets a day after a meal and need to drink more water. In this study, the participants need to take 2 tablets once daily after breakfast. The duration of the intervention will be 12 weeks. All participants are required to return to the clinic in the 6th and 12th week for a post-intervention assessment.
Control group
At baseline, the control group will receive a placebo drug consisting of Croscamellose Sodium, Microcrystalline Cellulose, Silicon Dioxide and Magnesium stearate. The placebo was manufactured by Yanling Natural Hygiene Sdn Bhd. The formulation of the placebo tablet is derived from the excipients used in the Bionerv tablet.
The participants need to take 2 tablets once daily after breakfast. The placebo drugs will share the same appearance and color as intervention drug.
The duration of the intervention will be 12 weeks. All participants are required to return to the clinic in the 6th and 12th week for a post-intervention assessment.
Follow up
There are two follow-ups during this study. 1st follow-up will be on the 6th week and 2nd follow-up (final follow-up) will be during 12th week of the study.
During the 6th week follow-up, participants will be checked for their weight, height, calculated Body Mass Index (BMI), TSS, NSS, RV-DQoL questionnaire, compliance, and adverse effects.
A final visit (12th week) to the clinic will be conducted on the 12th week. During these visits, the outcome measures will be assessed to determine the effect of the fixed-dose combination of alpha lipoic acid and vitamin B. During this visit, the same measurement will be taken as visit 1.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- Alpha-Lipoic Acid/Vitamin/Mineral Supplement PolyMVA
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Lipoic Acid/Vitamin/Mineral Supplement PolyMVADrug
Also called BIONERV
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.
| Study group | Role | What they receive |
|---|---|---|
| Bionerve | Experimental | The participants will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations. Receives: Drug: Alpha-Lipoic Acid/Vitamin/Mineral Supplement PolyMVA |
| Placebo | No intervention | The participants will receive a placebo (look-alike substance that contains no drug)l |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 weeks and 3 month
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.
Measured: baseline, 6 weeks and 3 month
Secondary outcomes (10)
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.
Measured: baseline and 3 month
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.
Measured: baseline and 3 month
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.
Measured: baseline and 3 month
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.
Measured: baseline and 3 month
compare the changes in diabetes quality of life over 12 a week period
using the revised version of Diabetes Quality of Life (Rv-DQoL) questionnaire. DQoL used for evaluating the quality of life specifically related to Type 2 Diabetes Mellitus patient and was made up of three major domains, namely, (i) Diabetes Life Satisfaction (QoL Satisfy), 18 items; (ii) Disease Impact Scale (QoL Impact), 27 items; and (iii) Disease-Related Worries Scale (QoL Worry), 14 items and one general question to reflect self-rating of overall general health. All items in the QoL Satisfy domain are scored on a five-point scale, ranging from 1 (very satisfied) to 5 (very dissatisfied), whereas the items in the QoL Impact and QoL Worry are scored on a five-point scale, ranging from 1 (never) to 5 (all the time); the score was presented as the total of the items of each scale divided by the number of items. A higher average score indicates poorer QoL.
Measured: baseline, 6 weeks and 3 month
compare the differences in the safety parameters of renal function
The test conducted to assess kidney function include Blood Urea Nitrogen (BUN), Serum Creatinine and Estimated Glomerular Filtration Rate (eGFR). Blood Urea Nitrogen (BUN) measure in mg/dL which the Normal Range: 7 to 20 mg/dL. Serum Creatinine measure in Micromoles per liter (µmol/L) Normal Range for Men: Approximately 70 to 120 µmol/L while Women: Approximately 50 to 100 µmol/L. Estimated Glomerular Filtration Rate (eGFR) normal range: 90 to 120 mL/min/1.73 m². Values below 60 mL/min/1.73 m² suggest CKD (Chronic Kidney Disease).
Measured: baseline and 3 month
compare the differences in the safety parameters of liver function
Liver function tests (LFTs) in encompass a range of blood tests that assess the health and function of the liver. This include: 1) Alanine Aminotransferase (ALT) which typically below 40 international units per liter (IU/L) for men and below 30 IU/L for women. 2) Aspartate Aminotransferase (AST) with normal range usually below 40 IU/L for both men and women. 3) Alkaline Phosphatase (ALP) varies by age and gender, typically between 30 and 120 IU/L.
Measured: baseline and 3 month
compare the changes in participant weight.
participant weight will be measure in kilograms (kg) using electronic bathroom scale.
Measured: baseline, 6 weeks and 3 month
participant height.
participant height measurement will be measure using a stadiometer. It consists of a vertical ruler and a movable headpiece that is adjusted to rest on the top of the head. Height measurement is in Centimeters (cm).
Measured: baseline
compare the changes in participant Body Mass Index (BMI)
Body Mass Index (BMI) is used to measure whether a person is underweight, normal weight, overweight, or obese. It is calculated by dividing weight in kilograms by height in meters squared (BMI = weight(kg) / height(m)^2). In Malaysia, the Clinical Practice Guidelines (CPG) on the Management of Obesity provide specific classifications for Body Mass Index (BMI) to identify and manage obesity. Underweight: BMI < 18.5. Normal Weight: BMI 18.5-22.9. Overweight: BMI 23.0-27.4. Obesity Class I: BMI 27.5-34.9. Obesity Class II: BMI 35.0-39.9. Obesity Class III (Morbid Obesity): BMI ≥ 40.0.
Measured: baseline, 6 weeks and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start27 May 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants then will be randomized to either intervention or control group. The intervention group will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations, and the control group will receive a placebo (look-alike substance that contains no drug).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- BREGO Life Sciences Sdn Bhd
- Responsible party
- Principal investigator, Che Nur Ain binti Che Abdullah, Universiti Sains Malaysia
- Investigators
- Che Nur Ain Che Abdullah, Dr., Principal investigator, Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health CampusNoraini Mohamad, Dr., Study director, Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health CampusNani Draman, Prof. Dr., Study chair, Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health CampusRitzzaleena Rosli Mohd Rosli, Dr., Study chair, Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health CampusZainab Mat Yudin@Badrin, Dr., Study chair, Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568185
- Sponsor's protocol ID
- USM/JEPeM/KK/23110893
- Status last verified
- Aug 2024
- First submitted
- 6 May 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06568185
- Acronym / sponsor ID
- USM/JEPeM/KK/23110893
- Conditions
- Diabetic Polyneuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- BREGO Life Sciences Sdn Bhd
- Study start
- 27 May 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
General objective
To determine the effectiveness of a fixed dose combination of alpha lipoic acid and vitamin B preparations in comparison with incative drug for treatment of diabetic polyneuropathy (DPN) in people with type 2 diabetes mellitus.
Research hypothesis
- There are significant improvements in mean total symptom score (TSS) and neuropathic symptoms score (NSS) in people with diabetic polyneuropathy taking a fixed dose combination of alpha lipoic acid and vitamin B preparations as compared to diabetic polyneuropathy patients taking a placebo.
- There are significant improvements in total symptom score (TSS) and neuropathic symptoms score (NSS) among people with diabetic polyneuropathy taking a fixed dose combination of alpha lipoic acid and vitamin B preparations for 12 weeks.
- There are significant improvements in fasting plasma glucose, HbA1C level, fasting lipid profile, body mass index (BMI), and diabetes quality of life in people with diabetes taking a fixed dose combination of alpha lipoic acid and vitamin B preparations as compared to diabetic patients taking placebo.
- There are no significant differences in the safety parameters of renal function and liver function tests among people with diabetic polyneuropathy at baseline and 12 weeks after taking a fixed dose combination of alpha lipoic acid and vitamin B preparations.
- There are significant improvements in fasting plasma glucose, HbA1C level, fasting lipid profile, body mass index (BMI), and diabetes quality of life among diabetic patients taking a fixed dose combination of alpha lipoic acid and vitamin B preparations for 12 weeks.
Method of data collection
This study will be conducted after obtaining approval from the Universiti Sains Malaysia Ethical Committee (JPeM) and will be conducted in accordance to World Medical Association Declaration of Helsinki ethical principles for medical research involving human subjects.
Recruitment of subject
Participants will be recruited from Klinik Rawatan Keluarga and diabetes clinic Hospital USM via convenience sampling. Potential participants will be identified from the case notes of patients. Then, the participants will be approached individually. Those who are willing to participate in this study will be given information regarding the study. The participants will be screened to determine their eligibility criteria, including performing neurological symptom score (NSS) and neuropathy disability score (NDS) to determine diabetes polyneuropathy diagnosis. If all the inclusion and exclusion criteria are fulfilled, informed consent will be obtained from all patients who agree to participate in this study. The consent will be obtained by a study team that recruited the patient. Upon consented, the participant's socio-demographic data will be collected, and the medical record will be assessed to fill in their medical and diabetes profiles. They will also answer the total symptoms score (TSS), and revised version of the Diabetes Quality of Life (Rv-DQoL) questionnaire. The physical examination includes measurement of height, weight, calculated Body Mass Index (BMI), and blood pressure during sitting will be done. Then 6ml of fasting venous blood will be taken for measurement of HbA1c, fasting blood glucose, renal function test, liver function test and fasting lipid profile as baseline. All participants were advised not to consume any special supplement or other replacement meal throughout the study.
The participants then will be randomized to either intervention or control group. The intervention group will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations, and the control group will receive a placebo (look-alike substance that contains no drug).
The participants will be seen 6 weeks after taking the product. During this visit, they will be assessed for any side effects or adverse events and compliance with the product supplied (compliance form). The total symptoms score (TSS), neurological symptom score (NSS), a revised version of Diabetes Quality of Life (Rv-DQoL), blood pressure, weight, height, calculated Body Mass Index (BMI) will also be measured. Another 6-week supply of the product will be given.
Lastly, the participants will be assessed in week 12. During this visit, the same measurement will be taken as visit 1, including answering the questionnaires. Adverse events, blood taking, and compliance will also be assessed.
The duration for visit 1 and visit 3 (at 12 weeks) is about 50-60 minutes for each visit since it will involve blood taking procedure. Duration for visit 2 (at 6 weeks) is about 30 minutes since it will not involve blood taking.
Intervention group: Fixed dose combination of alpha lipoic acid and vitamin B preparations
At baseline, the intervention group will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations. This product is packaged and manufactured by BREGO Life Sciences Sdn Bhd company with a brand name of Bionerv®. BIONERV® is 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. All the above ingredients are synthetic. The shelf-life is 2 years. Storage condition is keeping in dry place below 300oC and protecting from light and moisture. It has no bovine-gelatin capsule. There are no precautions on drug-drug interaction, but it is not suitable for children (<18 years). There is insufficient reliable data for pregnancy and breast feeding. One bottle consists of 60 tablets.
This medication needs to take 2 tablets a day after a meal and need to drink more water. In this study, the participants need to take 2 tablets once daily after breakfast. The duration of the intervention will be 12 weeks. All participants are required to return to the clinic in the 6th and 12th week for a post-intervention assessment.
Control group
At baseline, the control group will receive a placebo drug consisting of Croscamellose Sodium, Microcrystalline Cellulose, Silicon Dioxide and Magnesium stearate. The placebo was manufactured by Yanling Natural Hygiene Sdn Bhd. The formulation of the placebo tablet is derived from the excipients used in the Bionerv tablet.
The participants need to take 2 tablets once daily after breakfast. The placebo drugs will share the same appearance and color as intervention drug.
The duration of the intervention will be 12 weeks. All participants are required to return to the clinic in the 6th and 12th week for a post-intervention assessment.
Follow up
There are two follow-ups during this study. 1st follow-up will be on the 6th week and 2nd follow-up (final follow-up) will be during 12th week of the study.
During the 6th week follow-up, participants will be checked for their weight, height, calculated Body Mass Index (BMI), TSS, NSS, RV-DQoL questionnaire, compliance, and adverse effects.
A final visit (12th week) to the clinic will be conducted on the 12th week. During these visits, the outcome measures will be assessed to determine the effect of the fixed-dose combination of alpha lipoic acid and vitamin B. During this visit, the same measurement will be taken as visit 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The participants then will be randomized to either intervention or control group. The intervention group will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations, and the control group will receive a placebo (look-alike substance that contains no drug).
| Arm | Type | Receives |
|---|---|---|
| Bionerve | Experimental | Drug: Alpha-Lipoic Acid/Vitamin/Mineral Supplement PolyMVAThe participants will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations. |
| Placebo | No intervention | –The participants will receive a placebo (look-alike substance that contains no drug)l |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-Lipoic Acid/Vitamin/Mineral Supplement PolyMVAAlso: BIONERVBIONERV® 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. | Drug | Bionerve |
Primary outcome
To compare the mean change in Total symptom score (TSS) over 12 a week period
Time frame: baseline, 6 weeks and 3 month
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
Time frame: baseline, 6 weeks and 3 month
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.
10 secondary outcomes
compare the changes in the fasting plasma glucose over 12 a week period
Time frame: baseline and 3 month
compare the changes in the fasting lipid profile over 12 a week period
Time frame: baseline and 3 month
compare the changes in the HbAIC level over 12 a week period
Time frame: baseline and 3 month
compare the changes in blood pressure over 12 a week period
Time frame: baseline and 3 month
compare the changes in diabetes quality of life over 12 a week period
Time frame: baseline, 6 weeks and 3 month
compare the differences in the safety parameters of renal function
Time frame: baseline and 3 month
compare the differences in the safety parameters of liver function
Time frame: baseline and 3 month
compare the changes in participant weight.
Time frame: baseline, 6 weeks and 3 month
participant height.
Time frame: baseline
compare the changes in participant Body Mass Index (BMI)
Time frame: baseline, 6 weeks and 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Che Nur Ain Che Abdullah, Dr. principal investigator
Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus
Noraini Mohamad, Dr. study director
Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus
Nani Draman, Prof. Dr. study chair
Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alpha-Lipoic Acid/Vitamin/Mineral Supplement PolyMVA in people with Diabetic Polyneuropathy, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Che Nur Ain Che Abdullah, Dr. (+60199216023, chenurain@student.usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the mean change in Total symptom score (TSS) over 12 a week period (time frame: baseline, 6 weeks and 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.