Status:
RECRUITING
The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient
Lead Sponsor:
Universiti Sains Malaysia
Collaborating Sponsors:
BREGO Life Sciences Sdn Bhd
Conditions:
Diabetic Polyneuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
General objective To determine the effectiveness of a fixed dose combination of alpha lipoic acid and vitamin B preparations in comparison with incative drug for treatment of diabetic polyneuropathy ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
May 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06568185
Start Date
May 27 2024
End Date
September 1 2025
Last Update
August 23 2024
Active Locations (1)
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1
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150