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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Malaysia
Hospital Universiti Sains Malaysia
RECRUITING
Kubang Kerian
Contact Information
Primary
Che Nur Ain Che Abdullah, Dr.
chenurain@student.usm.my
+60199216023
Backup
Noraini Mohamad, Dr.
mnoraini@usm.my
+60139855968
Time Frame
Start Date: 2024-05-27
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 76
Treatments
Experimental: Bionerve
The participants will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations.
No_intervention: Placebo
The participants will receive a placebo (look-alike substance that contains no drug)l
Related Therapeutic Areas
Sponsors
Leads: Universiti Sains Malaysia
Collaborators: BREGO Life Sciences Sdn Bhd

This content was sourced from clinicaltrials.gov