Effect of Alpha Lipoic Acid and Vitamin B on Diabetic Nerve Damage in Type 2 Diabetes
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
PHASE2 · Universiti Sains Malaysia · NCT06568185
This study is testing if a mix of alpha lipoic acid and vitamin B can help people with type 2 diabetes who have nerve damage feel better over 12 weeks.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universiti Sains Malaysia (other) |
| Locations | 1 site (Kubang Kerian, Kelantan) |
| Trial ID | NCT06568185 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a combination of alpha lipoic acid and vitamin B preparations in treating diabetic polyneuropathy in patients with type 2 diabetes mellitus. It is a single-center, randomized, double-blind, placebo-controlled study that will assess improvements in neuropathic symptoms and overall diabetes management over a 12-week period. Participants will be monitored for changes in symptom scores, glucose levels, and other health indicators. The study will take place at the Klinik Rawatan Keluarga and diabetes clinic at Hospital Universiti Sains Malaysia from May 2024 to September 2025.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over diagnosed with type 2 diabetes mellitus and diabetic polyneuropathy.
Not a fit: Patients with peripheral vascular disease, renal impairment, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve nerve function and quality of life for patients suffering from diabetic polyneuropathy.
How similar studies have performed: Previous studies have shown promising results with similar combinations of alpha lipoic acid and vitamin B for diabetic neuropathy, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 years and over 2. Diagnosed with type 2 diabetes mellitus based on WHO diagnostic criteria for diabetes (Organization, 2020). 3. Diagnose with diabetic polyneuropathy by Neurological Symptom Score (NSS) and Neuropathy Disability Score (NDS). Exclusion Criteria: 1. Those with a documented mental impairment which impacted on their ability to answer questions independently. 2. People with peripheral vascular disease (non-palpable foot pulses, intermittent claudication) 3. People with an amputated foot or leg 4. Abnormal liver enzyme. 5. People with renal impairment. 6. People using drugs with possible influence on the study results (antidepressants, anticonvulsants, opiates, neuroleptics, antioxidants, and particularly methylcobalamin, pyridoxine and other B complex preparations) 7. Pregnancy, lactation, or childbearing age without safe contraception 8. History of allergy with vitamin B complex preparations (i.e. Vitamin B12, B6 and B1) and alpha lipoic acid.
Where this trial is running
Kubang Kerian, Kelantan
- Hospital Universiti Sains Malaysia — Kubang Kerian, Kelantan, Malaysia (RECRUITING)
Study contacts
- Principal investigator: Che Nur Ain Che Abdullah, Dr. — Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus
- Study coordinator: Che Nur Ain Che Abdullah, Dr.
- Email: chenurain@student.usm.my
- Phone: +60199216023
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Polyneuropathy