A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF BHUNIMBADI CHURNA ORALLY WITH PANCHATIKTA KASHAYA PARISHEK AND PREGABALIN IN DIABETIC SENSORY POLYNEUROPATHY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Diabetic sensory polyneuropathy is a common and progressive complication of diabetes mellitus characterized by numbness burning sensation tingling pain and sensory loss predominantly in the lower limbs. It significantly reduces quality of life and may lead to serious complications. Current management mainly includes glycemic control and symptomatic treatment such as Pregabalin however long term relief and disease modification remain challenging.
In Ayurveda diabetic sensory polyneuropathy can be correlated with Madhumehajanya upadrava and Vata Pitta involvement. Bhunimbadi Churna mentioned in Ashtanga Hridaya along with Panchatikta Kashaya Parishek is described for conditions involving Kushtha Meha and Suptata and may provide neuroprotective and anti inflammatory effects.
This study is a randomized parallel group controlled clinical trial planned to evaluate the efficacy of Bhunimbadi Churna 1 gram twice daily with Madhu and Ghrita for 45 days along with Panchatikta Kashaya Parishek for 21 days in comparison to Pregabalin 75 mg twice daily for 45 days in patients aged 30 to 70 years suffering from diabetic sensory polyneuropathy.
A total of 60 participants will be randomly allocated into two groups with 30 participants in each group. Assessment will be done using Neuropathy Total Symptom Score 6 Toronto Clinical Neuropathy Score and required nerve conduction studies. Follow up assessments will be carried out on day 15 day 30 and day 45 with final assessment on day 50.
The primary objective is to evaluate and compare the efficacy of Ayurvedic intervention with standard modern treatment in reducing neuropathic symptoms. The results of this study may help in developing an evidence based Ayurvedic treatment protocol for diabetic sensory polyneuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Presence of one or more of the symptoms i.e allodynia, burning sensation, aching pain, pricking pain ect along with mild to severe impairment according to NTSS-6 score.
- •Patients of both sex of age between 30 to 70 years.
排除标准
- •Patients having any other associated clinical conditions influencing peripheral nerve function like peripheral vascular, anemia disorders will be excluded.
- •Patients having any of neuropathic complication i.e. Diabetic foot will be excluded.
- •Patients having chronic alcoholism will be excluded.
- •Patients contraindicated for the pregabalin.
- •Mrudu koshta person will be excluded.
研究者
Dr Gaurav Pradeep Bundela
Seth Govindji Raoji Ayurveda Mahavidylaya Solapur