The Effectiveness of Fixed Dose Combination of Alpha Lipoic Acid and Vitamin B Preparations for Treatment of Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patients: A Randomized Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- To compare the mean change in Neuropathic symptoms score (NSS) over 12 a week period
研究概览
简要总结
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.
详细描述
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 (DPN) in people with type 2 diabetes mellitus.
Research hypothesis
- There are significant improvements in mean total symptom score (TSS) and neuropathic symptoms score (NSS) in people with diabetic polyneuropathy taking a fixed dose combination of alpha lipoic acid and vitamin B preparations as compared to diabetic polyneuropathy patients taking a placebo.
- There are significant improvements in total symptom score (TSS) and neuropathic symptoms score (NSS) among people with diabetic polyneuropathy taking a fixed dose combination of alpha lipoic acid and vitamin B preparations for 12 weeks.
- There are significant improvements in fasting plasma glucose, HbA1C level, fasting lipid profile, body mass index (BMI), and diabetes quality of life in people with diabetes taking a fixed dose combination of alpha lipoic acid and vitamin B preparations as compared to diabetic patients taking placebo.
- There are no significant differences in the safety parameters of renal function and liver function tests among people with diabetic polyneuropathy at baseline and 12 weeks after taking a fixed dose combination of alpha lipoic acid and vitamin B preparations.
- There are significant improvements in fasting plasma glucose, HbA1C level, fasting lipid profile, body mass index (BMI), and diabetes quality of life among diabetic patients taking a fixed dose combination of alpha lipoic acid and vitamin B preparations for 12 weeks.
Method of data collection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Bionerve
The participants will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations.
干预措施: Alpha-Lipoic Acid/Vitamin/Mineral Supplement PolyMVA (Drug)
结局指标
主要结局
To compare the mean change in Neuropathic symptoms score (NSS) over 12 a week period
时间窗: baseline, 6 weeks and 3 month
Neurological Symptom Score consists of 4 components. The first component is on reported discomfort symptoms: burning/numbness/tingling (2 points), fatigue/cramping and aching feelings (1point) and 0 point for none. Second component is on symptom location whether the symptom occurs in the feet (2 points), calves (1 point) and 0 points for elsewhere. The third component is on timing of symptoms, either nocturnal exacerbation (2 points), symptoms present both day and night (1 point) and 0 for symptoms present during daytime only. A score of 1 was added if the symptoms had ever woken the patient from sleep. The fourth component is on a manoeuvre to reduce the symptoms by either walking (2 points) or standing (1pointand and 0 for sitting or lying down. The maximum symptom score was 9.
To compare the mean change in Total symptom score (TSS) over 12 a week period
时间窗: baseline, 6 weeks and 3 month
Total Symptom Score is the sum of 4 neuropathic symptoms (stabbing pain, burning pain, paraesthesia, and numbness) reported as symptoms frequency (occasionally, frequent, or continuous) and symptom intensity (absent, slight, moderate, or severe) on which scores range from 0 to 14.64.
次要结局
- compare the changes in the fasting lipid profile over 12 a week period(baseline and 3 month)
- compare the differences in the safety parameters of liver function(baseline and 3 month)
- compare the changes in participant weight.(baseline, 6 weeks and 3 month)
- compare the changes in participant Body Mass Index (BMI)(baseline, 6 weeks and 3 month)
- compare the changes in the fasting plasma glucose over 12 a week period(baseline and 3 month)
- compare the changes in the HbAIC level over 12 a week period(baseline and 3 month)
- compare the changes in blood pressure over 12 a week period(baseline and 3 month)
- compare the differences in the safety parameters of renal function(baseline and 3 month)
- compare the changes in diabetes quality of life over 12 a week period(baseline, 6 weeks and 3 month)
- participant height.(baseline)
研究者
Che Nur Ain binti Che Abdullah
Principal Investigator
Universiti Sains Malaysia