A PHYSICOCHEMICAL AND RANDOMIZED CONTROLLED CLINICAL STUDY OF PADMAKA (Prunus cerasoides D. DON) AS VEDANASTHAK IN SUPTI (NUMBNESS) W.S.R.TO DIABETIC NEUROPATHY.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study physicochemical properties and clinical efficacy of Padmak (Prunus cerasoides D. DON) as Vedanasthapak (establish densation at sensrless sight) in supti (numbness) w.s.r to diabetic neuropathy.
研究概览
简要总结
This is open parallel labelled , randomized , interventional , clinical controlled study, in which patients are grouped into 2, one is trial group in which 30 patients will be included for study they will recieve Padmak choorna in the dose of 1.5gm BD in Pragbhatka kala for 3 months and another controlled group will recieve Pregabalin 75mg with methylcobalamin 1500mcg OD for 3 months, primary focus of the clinical trial is to study physicochemical inmportantc and vedanasthak in supti that is numbness in diabetic neuropathy along with study on Tingling sensation (Hastapaad chimchamayan) and Burning Sensation (Hasta Paad tal daha) also, for objective study assesment will be done with the heko of filament test
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject willing to give written informed consent.2.Patients ready to comply trial protocol.
- •3.Both gender with Age between 30-70 years.
- •4.Patients diagnosed with Type 2 diabetes mellitus with evidence of clinical, symptomatic, symmetric, distal neuropathy with numbness.
- •5.Patients with atleast 7-8 years of duration of diabetes.
排除标准
- •1.Subjects not willing to give written informed consent.
- •2.Age below 30 and above 70 years 3.K/C/O of Leprosy, gangrene or where permanent nerve damage occurs.
- •HIV, or any other debelating disorders.
- •4.Patients who are not ready to comply the trial protocols.
- •6.Patients with Peripheral vascular disease.
- •7.Those on antidepressants, opiates, anticonvulsant, capsaicin and also an aldose deductase inhibitors.
结局指标
主要结局
To study physicochemical properties and clinical efficacy of Padmak (Prunus cerasoides D. DON) as Vedanasthapak (establish densation at sensrless sight) in supti (numbness) w.s.r to diabetic neuropathy.
时间窗: baseline and after every 15 days upto 3 months
• To see effect of Padmak as Vedanasthapak in Supti w.s.r to numbness in Diabetic neuropathy.
时间窗: baseline and after every 15 days upto 3 months
• To analyse pharmacognostic and physicochemical properties of Padmak.
时间窗: baseline and after every 15 days upto 3 months
• To co-relate Supti with diabetic neuropathy.
时间窗: baseline and after every 15 days upto 3 months
次要结局
- • To see effect of Padmak as Vedanasthapak in Supti w.s.r to numbness in Diabetic neuropathy.
- • To analyse pharmacognostic and physicochemical properties of Padmak.(1 month)
- •To co-relate Supti with diabetic neuropathy.(10 days)
研究者
Dr Ashashri Tulsiram Shinde
Yashwantrao Chavan Ayurvedic Medical College and Hospital