The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient

NCT06568185 | Recruiting Phase 2

• 1 other identifier: USM/JEPeM/KK/23110893
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Polyneuropathy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline, 6 weeks and 3 month

Secondary Outcomes (10)

• compare the changes in the fasting plasma glucose over 12 a week period

  baseline and 3 month

• compare the changes in the fasting lipid profile over 12 a week period

  baseline and 3 month

• compare the changes in the HbAIC level over 12 a week period

  baseline and 3 month

• compare the changes in blood pressure over 12 a week period

  baseline and 3 month

• compare the changes in diabetes quality of life over 12 a week period

  baseline, 6 weeks and 3 month

Study Arms (2)

Bionerve

EXPERIMENTAL

The participants will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations.

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

Interventions

Alpha-Lipoic Acid/Vitamin/Mineral Supplement PolyMVA DRUG

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.

Also known as: BIONERV

Bionerve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• BREGO Life Sciences Sdn Bhd: collaborator

Study Sites (1)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Che Nur Ain Che Abdullah, Dr.

  Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus

  PRINCIPAL INVESTIGATOR

• Noraini Mohamad, Dr.

  Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus

  STUDY DIRECTOR

• Nani Draman, Prof. Dr.

  Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus

  STUDY CHAIR

• Ritzzaleena Rosli Mohd Rosli, Dr.

  Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus

  STUDY CHAIR

• Zainab Mat Yudin@Badrin, Dr.

  Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus

  STUDY CHAIR

Central Study Contacts

Che Nur Ain Che Abdullah, Dr.

CONTACT

+60199216023; chenurain@student.usm.my

Noraini Mohamad, Dr.

CONTACT

+60139855968; mnoraini@usm.my

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: August 23, 2024
• Study Start: May 27, 2024
• Primary Completion: October 30, 2024
• Study Completion: September 1, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)