Single Centric Non- Randomized Open Clinical Trial Phase II in Karathambam among Madhumegam patients ( Diabetic Neuropathy ) with siddha medicine Brahmi nei among patients attending OPD at Government Siddha Medical College Hospital, Chennai
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Outcome will be assessed by:
研究概览
简要总结
Peripheral neuropathies are diseases of the peripheral nervous system that can be divided into mononeuropathies, multifocal neuropathies, and polyneuropathies.
The first symptoms tend to be sensory and consists of tingling, prickling, burning or bandlike dysesthesias in the balls of the feet or tip of the toes or in a general distribution over the soles.The tingling sensation started distally and limited in the “Glove and stocking†distribution.Peripheral Neuropathy may be due to various cause Hereditary, Metabolic causes,
Nutritional Deficiency, Connective tissue disorders, Infection, Toxins and Malignancy.
Diabetic Neuropathy is the most common cause of Peripheral neuropathy and it ranges from 54% among 1,00,000 people per year. In epidemiological studies from India showed wide prevalence varying from 5 to 2400 per 10,000 population in different community studies.6 Peripheral Neuropathies progress slowly, over more than 5 years. Different clinical neurological scales can be used to assess the severity of Diabetic polyneuropathy. On the basis of NCBI Staging,
NO— No neuropathy
N1a— Signs but no symptoms of neuropathy
N2a— Symptomatic mild diabetic polyneuropathy
N2b— Severe symptomatic diabetic polyneuropathy (as in N2a but patient unable to heel walk)
N3— Disabling diabetic polyneuropathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •K/C/O of Type 2 Diabetes Mellitus more than 5 years Stage N2a and N2b (NCBI staging of Diabetic Neuropathy).
排除标准
- •Alcohol-associated neuropathy Nutritional linked neuropathy Uremic neuropathy Vulnerable people.
结局指标
主要结局
Outcome will be assessed by:
时间窗: 48 days
Measuring the reduction in severity of signs and symptoms using staging scales, such as transitioning from,
时间窗: 48 days
N2b to N2a/N1a/ NO
时间窗: 48 days
N2a to N1a/NO
时间窗: 48 days
N1a to NO
时间窗: 48 days
次要结局
- Measuring the reduction in severity of signs & symptoms
研究者
S Shalini
Government Siddha Medical College Arumbakkam, Chennai.
