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临床试验/CTRI/2024/05/068124
CTRI/2024/05/068124尚未招募2 期

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

SHALINI S1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月9日最近更新:

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

发起方
SHALINI S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

S Shalini

Government Siddha Medical College Arumbakkam, Chennai.

研究点 (1)

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