A Comparative Clinical Study To Evaluate The Effect Of Yashtimadhu Bhavita Shilajatu and Balamoola Bhavita Shilajatu In Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Vibration Perception Threshold (VPT) on BIOTHESIOMETER Before and After the Treatment
研究概览
简要总结
The aim of this study is to compare the effects of yashtimadhu bhavita shilajitu and balamoola bhavita shialajitu in diabetic peripheral neuropathy. 200 subjects satisfying diagnostic and inclusion criteria will be divided into 2 groups of 100 subjects each. Intervention will be given for 8 weeks. Post 8 weeks of intervention, the subjects will be assessed for changes in vibration perception threshold, diabetic neuropathy symptom questionnaire, diabetic neuropathy examination score, visual analogue scale and WHO quality of life.
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
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Metabolically stable diabetic Subjects with symptomatic Diabetic Peripheral Neuropathy. Subjects fulfilling the diagnostic criteria. Subjects whose HbA1c is between 6.5 to 9%. Subjects of all gender between the age group of 40.
排除标准
- •Subjects whose HbA1c is more than 9%.
- •Subjects with other metabolic and endocrinal disorders.
- •Subjects with other causes of Polyneuropathy.
- •Subjects suffering from infectious diseases and non healing ulcer/ulcers.
- •Subjects with cardiac aliments and Nephropathy.
- •Subjects with Diabetic Neuropathy in stage N3 of Dyck’s staging.
结局指标
主要结局
Vibration Perception Threshold (VPT) on BIOTHESIOMETER Before and After the Treatment
时间窗: 1st Assessment – Before Treatment (0th day) | 2nd Assessment – During Treatment (31st day) | 3rd Assessment – During Treatment (61st day) | 4th Assessment – After Treatment (91st day)
次要结局
- Diabetic Neuropathy Symptom (DNS) questionnaire Score Before and After the Treatment(Diabetic Neuropathy Examination Score (DNE) Before and After the Treatment)
研究者
Dr Rakesh
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital