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

NCT06568185 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-08-23

No results posted yet for this study

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

Interventions

DRUG

Alpha-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.

Sponsors & Collaborators

  • BREGO Life Sciences Sdn Bhd

    collaborator UNKNOWN

  • Universiti Sains Malaysia

    lead OTHER

Principal Investigators

  • Che Nur Ain Che Abdullah, Dr. · Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus

  • Noraini Mohamad, Dr. · Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus

  • Nani Draman, Prof. Dr. · Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus

  • Ritzzaleena Rosli Mohd Rosli, Dr. · Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus

  • Zainab Mat Yudin@Badrin, Dr. · Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-27
Primary Completion
2024-10-30
Completion
2025-09-01

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06568185 on ClinicalTrials.gov