Evaluation Of Efficacy Of Vangeshwara Rasa In Diabetic Polyneuropathy- A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Vangeshwara Rasa is efficacious in managing the Diabetic Polyneuropathy.
研究概览
简要总结
Diabetes Mellitus is most prevalentnon communicable disease with common and serious complication like DiabeticPolyneuropathy (DPN). Diabetic Polyneuropathy isone of the most troublesome vascular complications of Diabetic Mellitus presentin 30 – 50 % of all Diabetics.Diabetes can be correlated with Madhumehain Ayurveda, but no equivalent explanation available for DPN.
Diabetic is the leadingcause of neuropathy ,and it is most common cause for complication and greatestsource of mortality and morbidity, one in 6 Diabetics has neuropathy is that upto 50 % Diabetics . Diabetic Polyneuropathy is major causefor lower limb amputation. The trial drug Vangeshwara Rasa is having sheetaveerya drug with kashaya and tikta rasa. Previous study shown that Vangeshwararasa is highly efficatious than Vanga bhasma(calyx) for controlling the bloodglucose level in Diabetic patients. Diabetic Polyneuropathy issevere but frequently reported andinadequately treated , so there is a need of further research .
With this background hereis an attempt made to find out effective Ayurvedic formulation to treatDiabetic Polyneuropathy. The formulations which are explained in classics forPrameha in classics have been selected for the present study they areGuduchyadi Kwatha and Vangeshwara Rasa.Hence the present study is aimed to knowthe efficacy and safety of these formulations in the management of Diabetic Polyneuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Metabolically stable diagnosed TYPE 2 Diabetes Mellitus (i.e FBS >126 & <140mg/dL AND PPBS >140mg/dL) patients with symptomatic Diabetic Polyneuropathy.
- •2.Patients on Anti- diabetic medications will be included.
- •3.Patient of irrespective of sex, religion and socioeconomic status.
- •4.Patients with TCSS score between 6- 11.
排除标准
- •1.Pregnant and lactating women.
- •2.Patients with other complications of DM such as Nephropathy, Retinopathy and Vasculopathy.
- •3.Patients with other metabolic and endocrinal disorders.
- •4.Patients with other causes of Neuropathy.
- •5.Patients with wound or ulcer.
结局指标
主要结局
Vangeshwara Rasa is efficacious in managing the Diabetic Polyneuropathy.
时间窗: 0th, 15th, 30th, 46th day
Reduction in clinical Signs and symptoms of Diabetic Polyneuropathy.
时间窗: 0th, 15th, 30th, 46th day
次要结局
- Not Applicable(Not Applicable)