Actively Recruiting
The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient
Led by Universiti Sains Malaysia · Updated on 2024-08-23
76
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
Sponsors
U
Universiti Sains Malaysia
Lead Sponsor
B
BREGO Life Sciences Sdn Bhd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years and over
- Diagnosed with type 2 diabetes mellitus based on WHO criteria
- Diagnosed with diabetic polyneuropathy by Neurological Symptom Score (NSS) and Neuropathy Disability Score (NDS)
You will not qualify if you...
- Documented mental impairment affecting ability to answer questions
- Peripheral vascular disease (non-palpable foot pulses, intermittent claudication)
- Amputated foot or leg
- Abnormal liver enzyme levels
- Renal impairment
- Use of drugs affecting study results (antidepressants, anticonvulsants, opiates, neuroleptics, antioxidants, or B complex vitamins)
- Pregnancy, lactation, or childbearing age without safe contraception
- History of allergy to vitamin B complex or alpha lipoic acid
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150
Actively Recruiting
Research Team
C
Che Nur Ain Che Abdullah, Dr.
CONTACT
N
Noraini Mohamad, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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