Type 2 diabetes mellitus is diagnosed with diabetes polyneuropathy by neurological symptom score and neuropathy disability score alpha-lipoic acid, diabetic peripheral neuropathy, neuropathy symptom score, neuropathy disability score, total symptoms score
Conditions
Interventions
Each tablet contains 4 active ingredients as follows
1. Alpha lipoic acid 300mg
2. Vitamin B12 or methylcobalamin 500mcg
3. Vitamin B6 or pyridoxine 8mg
4. Vitamin B1 or thiamine 39mg
This medication
Placebo Comparator Drug,Placebo Comparator Drug
fixed dose combination of alpha lipoic acid and vitamin B preparations,Placebo
Sponsors
BREGO Life Sciences Sdn. Bhd.
Zainab Mat Yudin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosed with type 2 diabetes mellitus based on the WHO diagnostic criteria for diabetes 2. Diagnose with diabetic polyneuropathy by neurological symptom score and neuropathy disability score, with presence of moderate signs, neuropathy disability scores more than 6 OR mild signs of neuropathy disability score more than 3 and moderate symptoms of neurological symptom score more than 5.
Exclusion criteria
Exclusion criteria: 1. Those with a documented mental impairment which impacted their ability to answer questions independently. 2. Patients with peripheral vascular disease of non-palpable foot pulses, intermittent claudication 3. Patients with an amputated foot or leg 4. Aspartate aminotransferase or alanine aminotransferase levels more than 3 times the normal levels 5. Patients with renal impairment of Chronic Kidney Disease stages IV and V 6. Patients using drugs with possible influence on the study results, such as antidepressants, anticonvulsants, opiates, neuroleptics, antioxidants, and particularly methylcobalamin, pyridoxine and other B complex preparations 7. Pregnancy, lactation, or childbearing age without safe contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total symptom score and neuropathic symptoms score 6 weeks and 12 weeks total symptom score and neuropathic symptoms score | — |
Secondary
| Measure | Time frame |
|---|---|
| metabolic parameters , safety profiles and quality of life and 6 weeks and 12 weeks Metabolic profile of HbA1c, fasting blood sugar , fasting lipid profile, body mass index, blood pressure , safety profile of renal and liver function test and Quality of life Questionnaire | — |
Countries
Malaysia
Contacts
Public ContactNoraini Mohamad
School of Dental Sciences, Health Campus, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia
Outcome results
None listed