NCT06568185 The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient
| NCT ID | NCT06568185 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Universiti Sains Malaysia |
| Condition | Diabetic Polyneuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2024-05-27 |
| Primary Completion | 2024-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 76 participants in total. It began in 2024-05-27 with a primary completion date of 2024-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Che Nur Ain Che Abdullah, Dr.
PRINCIPAL INVESTIGATOR
Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus
Frequently Asked Questions
Who can join the NCT06568185 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Polyneuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06568185 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06568185 currently recruiting?
Yes, NCT06568185 is actively recruiting participants. Contact the research team at chenurain@student.usm.my for enrollment information.
Where is the NCT06568185 trial being conducted?
This trial is being conducted at Kubang Kerian, Malaysia.
Who is sponsoring the NCT06568185 clinical trial?
NCT06568185 is sponsored by Universiti Sains Malaysia. The principal investigator is Che Nur Ain Che Abdullah, Dr. at Department of Family Medicine, School of Medical Sciences University Sains Malaysia, Health Campus. The trial plans to enroll 76 participants.