The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Diabetic Polyneuropathy
In brief
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.
Key facts
- Study ID
- NCT06568185
- Run by
- Universiti Sains Malaysia
- People needed
- 76
- Starts
- 2024-05-27
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2024-08-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Hospital Universiti Sains Malaysia — Kubang Kerian, Kelantan, Malaysia (enrolling)
Full record on ClinicalTrials.gov
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