A clinical study to evaluate the therapeutic efficacy of panchtikta basti Followed by shamana chikitsa (palash arka) in the management of Madhumeha (diabetes mellitus)
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in classical signs and symptoms of Madhumeha
研究概览
简要总结
This is a single arm open label prospective clinical trial to evaluate the therapeutic efficacy of Panchtikta Basti followed by Shamana Chikitsa with Palash Arka in the management of Madhumeha which correlates with Type 2 Diabetes Mellitus A total of 30 patients aged between 20 to 60 years having classical signs and symptoms of Madhumeha will be selected The study includes 15 days of Panchtikta Basti therapy in 3 cycles with Niruha and Anuvasana Basti followed by 45 days of oral administration of Palash Arka The effects will be assessed based on subjective symptoms and objective parameters like fasting and postprandial blood sugar and urine sugar levels
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to give written consent Patients of non insulin dependent diabetes mellitus with fasting blood sugar between 126 to 300 mg per dl or post prandial blood sugar between 180 to 400 mg per dl Patients having classical signs and symptoms of Prameha according to Ayurveda and modern medicine.
排除标准
- •Patients below 20 years and above 60 years of age Patients of Prameha with chronicity more than 20 years Patients of Type 1 diabetes or Type 2 diabetes who are taking insulin Patients having serious complications like diabetic nephropathy neuropathy retinopathy diabetic foot or carbuncles Patients with drug or chemically induced Type 2 diabetes such as from glucocorticoids or thyroid hormones Diabetes associated with carcinoma or other systemic illnesses Pregnant and lactating women Patients unfit for Basti Karma.
结局指标
主要结局
Improvement in classical signs and symptoms of Madhumeha
时间窗: Baseline 15th day 30th day and 60th day
Improvement in fasting and postprandial blood sugar levels
时间窗: Baseline 15th day 30th day and 60th day
Improvement in urine sugar level
时间窗: Baseline 15th day 30th day and 60th day
次要结局
- Assessment of general well being and quality of life after therapy(Baseline and 60th day)
研究者
Nihit Mathur
PG Department of Panchkarma Post Graduate Institute of Ayurveda