Actively Recruiting
Led by Universiti Sains Malaysia · Updated on 2024-08-23
76
Participants Needed
1
Research Sites
43 weeks
Total Duration
U
Universiti Sains Malaysia
Lead Sponsor
B
BREGO Life Sciences Sdn Bhd
Collaborating Sponsor
Researchers are evaluating the effectiveness of a fixed-dose combination of alpha lipoic acid and vitamin B preparations for treating diabetic polyneuropathy in people with type 2 diabetes mellitus. This randomized, double-blind, placebo-controlled trial aims to compare this combination against a placebo to assess improvements in symptoms, blood sugar control, lipid levels, body weight, and quality of life over 12 weeks. Participants will be randomly assigned to receive either the fixed-dose combination or a placebo. The combination includes alpha lipoic acid 300mg, vitamin B12 500mcg, vitamin B6 8mg, and vitamin B1 39mg, taken as two tablets once daily after breakfast for 12 weeks. The study includes visits at baseline, 6 weeks, and 12 weeks to monitor treatment effects, compliance, and any side effects. During the study, participants will complete questionnaires on symptoms and quality of life and undergo physical exams including weight, height, and blood pressure measurements. Blood samples will be collected to measure glucose, HbA1c, lipid profile, and safety labs for liver and kidney function. Researchers will compare symptom scores and biochemical measures at baseline, 6 weeks, and 12 weeks to evaluate the treatment's impact. The total visit time ranges from 30 to 60 minutes depending on procedures performed.
CONDITIONS
The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take either a fixed dose combination of alpha lipoic acid and vitamin B preparations or a placebo daily for 12 weeks to treat diabetic polyneuropathy.
3 visits at baseline, 6 weeks, and 12 weeks
Total: 1 location
1
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150
Actively Recruiting
C
Che Nur Ain Che Abdullah, Dr.
N
Noraini Mohamad, Dr.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Nani Draman, Che Nur Ain Che Abdullah, Noraini Mohamad...
https://pubmed.ncbi.nlm.nih.gov/41935358