AN OPEN NON-RANDOMIZED SINGLE CENTRIC CLINICAL TRIAL TO EVALUATE THE EFFICACY OF VELLARUGU CHOORANAM IN THE MANAGEMENT OF KARATHAMBA VAATHAM (DIABETIC PERIPHERAL NEUROPATHY) 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
- To determine the therapeutic effect of Vellarugu Chooranam for the treatment of
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 . Peripheral Neuropathy may be due to various cause Hereditary, Metabolic causes, Nutritional Deficiency,Connective tissue disorders, Infection, Toxins and Malignancy . 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 general distribution over the soles .The tingling sensation started distally and limited in the “Glove and stocking” distribution. Diabetic neuropathy (DN) is a common disorder and is defined as signs and symptoms of peripheral nerve dysfunction in a patient with diabetes mellitus (DM) in whom other causes of peripheral nerve dysfunction have been excluded. There is a higher prevalence of DM in India (4.3%) probably Asian Indians are more prone for insulin resistance and cardiovascular mortality. India ranks second worldwide with a prevalence of 10.5–32.2% in the type 2 diabetes population (T2DM) and 26% to 51% of diabetic peripheral neuropathy (DPN). In epidemiological studies from India showed wide prevalence varying from 5 to 2400 per 10,000 population indifferent community studies. Siddha medicine “Vellarugu Chooranam”mentioned in Siddha Literature for the treatment of “Karathamba vaatham” (Diabetic Peripheral Neuropathy) patients is considered to evaluate the efficacy using Michigan Screening instrument.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •If the patients fall under, in any of the following three (2013 WHO Diabetic diagnostic criteria)Blood sugar fasting more than 126 and equal to or less than 200 mg /dl (or) Postprandial Blood Sugar more than 200 mg/dl and equal to or less than 350 mg /dl (or).
- •Glycated hemoglobin (HbA1c) more than 7percentage and less than 13 percentage Michigan Neuropathy Screening Instrument (MNSI) – Examination score more than or equal to 2.5 considered positive for neuropathy total score out of 5 and MNSI Questionnaires score more than or equal to 7 considered positive for presence of neuropathy total score out of
- •Patients already under medication for Madhumegam.
- •Already diagnosed DM patients with clinical symptoms.
排除标准
- •Age more than 60 years Insulin Dependent Diabetes Mellitus Autonomic neuropathy Alcohol-associated neuropathy Nutritional linked neuropathy Secondary Thyroid disorder Uremic neuropathy Subjects with severe systemic illness Subjects who are unwilling or unable to comply with the trial protocol.
结局指标
主要结局
To determine the therapeutic effect of Vellarugu Chooranam for the treatment of
时间窗: 1 year
Karathamba vaatham (Diabetic Peripheral Neuropathy) patients on the basis of Michigan
时间窗: 1 year
Neuropathy Screening Instrument (MNSI) and HbA1C
时间窗: 1 year
次要结局
- To determine the aldose reductase inhibition assay of the Siddha medicine Vellarugu Chooranam through invitro method(3 Months)
