A Randomized Double Arm Comparative Clinical Study to Evaluate the Efficacy of Dashamula Kashaya and Mahamanjishtadi Kashaya Along with Sthanika Abhyanga in the Management of Prameha Upadrava vis a vis Diabetic Peripheral Sensory Neuropathy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
Diabetic Peripheral Neuropathy is a common complication of Type 2 Diabetes Mellitus characterized by numbness tingling burning sensation pain and sensory impairment mainly in the lower limbs In Ayurveda this condition can be correlated with Prameha Upadrava involving predominantly Vata Dosha
This is a randomized double arm comparative clinical study conducted on 40 subjects diagnosed with Diabetic Peripheral Neuropathy Subjects will be randomly divided into two groups with 20 subjects in each group
Group A will receive Dashamoola Kashaya along with Sthanika Abhyanga using Chinchadi Taila Group B will receive Mahamanjishtadi Kashaya along with Sthanika Abhyanga using Chinchadi Taila
The duration of treatment will be 45 days
Assessment will be done based on Diabetic Neuropathy Symptom Score Toronto Clinical Scoring System Visual Analogue Scale Two Point Discrimination Test and laboratory parameters like FBS PPBS and HbA1c
The study aims to evaluate and compare the efficacy of both treatment protocols in reducing the symptoms and improving the clinical condition of Diabetic Peripheral Neuropathy
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研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of Type 2 Diabetes Mellitus on OHA Oral Hypoglycaemic Agents with chronicity of 0to10 years will be included Subjects of Diabetic peripheral neuropathy with Diabetic Neuropathy Symptom Score.
- •DNS 1to4 will be included Subjects with Diabetic peripheral neuropathy between the age group of 40 to 65 years irrespective of gender religion occupation and socioeconomic status will be included Subjects with HBA1C level upto 10percent will be included Subjects with FBS 120 to 200mg/dl PPBS 220 to 300 mg/dl will be included Definition of fresh cases include freshly diagnosed and untreated cases of Diabetic peripheral neuropathy Definition of treated cases includes already diagnosed and treated cases of Diabetic peripheral neuropathy who had voluntarily discontinued the treatment with the washout period of 7 days.
排除标准
- •Subjects of Type 2 Diabetes Mellitus on Insulin therapy and with complications like diabetic nephropathy retinopathy infectious wounds gangrene and foot ulcers will be excluded Subjects with age group below 40yrs and above 65yrs will be excluded Subjects with HbA1C above 10percent and chronicity more than 10 yrs will be excluded Subjects with uncontrolled diabetes mellitus ie FBS more than200mg/dL and PPBS more than 300 mg/dL will be excluded Subjects with any other systemic disorders which interfere with the intervention will be excluded Subjects with other type of neuropathy like Autonomic and motor neuropathy are excluded.
研究者
Dr Swarooparani
AYURVEDA MAHAVIDYALAYA AND HOSPITALHUBBALLI