In-vitro analysis of anti-oxidant potential of vanadium metallicum 12c and validating through open label randomized control trial in Type ii Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in the Fasting Blood Sugar before and after treatment
研究概览
简要总结
Many studies have shown that free radicals are elevated in diabetes mellitus which further complicate the case so vanadium is an antioxidant metal and many studies shows that it has insulin mimicking properties thus helpful in diabetes but no study paper available in homoeopathy that proves its efficacy so ill screen patients of diabetes mellitus type ii in age group of 30-70 years with fasting blood sugar 150-200mg/dL or HbA1c 6.5-8% with no other complication of diabetes or any other comorbidities for one intervention group 40 patients i’ll give vanadium 12c and other 40 patient will take individualized homoeopthic treatment those who are attending NIH OPD & IPD kolkata. study period will be 18 months and intervention period will be 6 months. After study i’ll compare the change in FBS in both vanadium and individualised homoeopathic medicine efficacy.
patient will be enrolled after informed consent only available in hindi english and bengoli languages .
if any negative outcomes appears for detoriation of health condition of patients then study will be stopped and necessary measures for the betterment of patient will be taken .
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
- •Age groups 30-70 of both sex and of all Religion.
- •FBS 125- 150 mg/dl.
- •PPBS 200- 300 mg/dl.
- •HbA1C 6.5- 8 % Out of above 3 any two.
- •Patient willing to give written consent for participating in the study and complete follow-up during study.
- •Patients who are able to read Bengali/English/Hindi.
排除标准
- •Patients age below 30 and above
- •Patients having severe complications like hypoglycaemia, retinopathy, neuropathy, diabetic foot, malignancy, severe cardiac disorders, HbA1C above 8, FBS above 150 mg/dl, PPBS above 300mg/dl or any other comorbidities.
- •Immunocompromised patient.
- •Patient suffering from any severe psychiatric illness.
- •Patients not willing to give written consent.
- •Patients not willing to undergo any investigation, if needed.
- •Pregnant and lactating mothers.
结局指标
主要结局
Changes in the Fasting Blood Sugar before and after treatment
时间窗: 6 months
次要结局
- antioxidant values of vanadium met 12 C(within study period 6 months)
研究者
Sushma Naigotriya
National Institute of Homoeopathy