Assessment of Resveratrol, Alpha Lipoic Acid and Superoxide Dismutase on Oxidative Stress Biomarkers in Type 2 Diabetes Mellitus Patients With Neuropathy: A Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in nerve conduction latency, velocity and amplitude.
研究概览
简要总结
Type 2 DM subjects having numbness, tingling and paresthesia in hands and feet (neuropathy) will be recruited. Screening of neuropathy will be done by Michigan screening instrument. This will be followed by nerve conduction studies. Specific blood parameters will also be checked. The subjects will then be divided into four treatment arms. Three groups will receive single drug and the fourth one will receive all the three drugs. These will be given for four months. Follow up will be done every month. At the end of four months, they will be assessed for any improvement in neuropathy by using Michigan neuropathy instrument and nerve conduction studies. Blood parameters will also be measured again.
详细描述
Type 2 DM subjects having numbness, tingling and paresthesia in hands and feet (neuropathy) will be recruited. They will be screened by Michigan neuropathy scale. This is tool used for screening neuropathy. Subjects having a score equal to or greater then 4 will be examined for further evaluation. This will be followed by nerve conduction studies for objective assessment of neuropathy. For inclusion criteria the test performed will be HbA1c, CBC, ESR, RFTs and LFTs. After screening the baseline levels of Superoxide radical, Super oxide dismutase, Glutathione peroxidase and Malonaldehyde will be measured. The subjects will be randomly divided into four treatment arms. Group A will receive Triple regime antioxidant therapy including Resveratrol 1500 mg two times a day, Alpha lipoic acid 600 mg two times a day and Superoxide dismutase 250 mg once a day. Group B will receive Resveratrol 1500mg BD, Group C will be on Tab Alpha lipoic acid 600 mg BD and Group D will take Superoxide dismutase once a day. The subjects will be kept blinded about the medication. They will be followed every month in which their quality of life will be assessed using Nottingham health profile and neuropathy will be assessed by Michigan neuropathy scale. At the end of four months blood tests will again be performed to check the levels of Superoxide radical, Superoxide dismutase, Glutathione peroxidase and Malonaldehyde. NCS will be done to see any improvement in neuropathy.
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
- Single (Participant)
盲法说明
The participants will not be given information about the medication.
入排标准
- 年龄范围
- 40 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 Diabetes Mellitus
- •Age between 40-60 years
排除标准
- •Malignancy
- •Vitamin B12 deficiency
- •History of drug or alcohol abuse
- •Taking antioxidant treatment
- •History and baseline investigations for renal hepatic and haematological diseases
- •Pregnant or lactating women.
研究组 & 干预措施
Alpha lipoic Acid
This group will receive Tab Alpha lipoic acid 600mg BD
干预措施: Alpha lipoic acid (Drug)
Resveratrol+ Alpha lipoic acid +Superoxide dismutase
This group will receive Resveratrol 1500 mg BD Tab Alpha lipoic acid 600 mg BD Tab Superoxide dismutase 250 mg BD
干预措施: Resveratrol, Alpha lipoic acid, Super oxide dismutase (Drug)
Resveratrol
This group will receive Tab Resveratrol 1500 mg BD
干预措施: Resveratrol (Drug)
Superoxide dismutase
This group will receive Tab Superoxide dismutase 250mg BD
干预措施: Super Oxide Dismutase (Drug)
结局指标
主要结局
Change in nerve conduction latency, velocity and amplitude.
时间窗: 4 months
This will be assessed by doing Nerve conduction studies at the start and end of trial. The nerves examined will be Median and Ulnar nerves in upper limb both for motor and sensory conduction. In case of lower limbs motor nerve Peroneal and sensory Sural nerve will be examined.
Change in clinical symptoms of neuropathy.
时间窗: 4 months
1. It will be assessed by Michigan neuropathy screening instrument at the start of the trial, at the end of each month and at the conclusion of the trial. 2. Changes in Quality of life will be assessed by Nottingham health profile. 3. Safety and tolerability of treatment. Recording and evaluation of adverse events and side effects will be done throughout the treatment period
次要结局
- Levels of Malonaldehyde oxidative stress biomarker(4 months)
- levels of superoxide radical anion,(4 months)
- Levels of Superoxide dismutase and Glutathione peroxidase(4 months)
