Comparative evaluation of efficacy of Haridradigana Yoga Basti with Haridradigana ghana Vati and Metformin in the management of Diabetes Mellitus Type II (Prameha)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Relief in clinical features associated with Diabetes Mellitus Type II(Prameha)
研究概览
简要总结
Patients will be recruited from inclusion criteria
Objectives will be
1. Toassess the efficacy of HaridradiganaYoga Basti with Haridradigana GhanaVati over objective parameters i.e. Blood sugar levels (Fasting &Post Prandial), Urine Sugar level, HbA1c in Diabetes Mellitus Type II
2. Toassess the efficacy of Metformin overobjective parameters i.e. Bloodsugar levels (Fasting & PostPrandial), Urine Sugar level, HbA1c in Diabetes Mellitus Type II
To compare the efficacy of Haridradigana Yoga Basti with HaridradiganaGhana Vati and Metformin over objective parameters i.e. Blood sugar levels (Fasting & Post Prandial), UrineSugar level, HbA1c in Diabetes Mellitus Type II
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with either sex having age between 20 -60 years 2.Patients recently diagnosed for uncomplicated NIDDM (type 2 diabetes) and having Fasting blood sugar level ≥126 mg/dl Post meal blood sugar level ≥140 mg/dl 3.HbA1c ≥ 6.57 4.Old cases of type-2 DM not taking any other anti-hypoglycaemic drugs.
- •5.Diabetic Patients suffering from Controlled Hypertension (Blood Pressure not more than ≥140 mmHg or an average Diastolic Blood Pressure not more than ≥90 mmHg) 6.Patients willing to give informed consent 7.Patient fit for Basti Karma as per the Ayurvedic classics.
排除标准
- •1.Patients suffering from IDDM (Insulin dependent diabetes mellitus) & patient with Type -2 Diabetes on insulin therapy 2.Patients suffering from Juvenile Diabetes or Gestational diabetes (ICD – 10 criteria 024) 3.DM with complications e.g. Retinopathy, Nephropathy, neuropathy ,previous history of coma 4.Patients suffering from any current acute illness, uncontrolled hypertension.
结局指标
主要结局
Relief in clinical features associated with Diabetes Mellitus Type II(Prameha)
时间窗: 1/2 month(45 days)
次要结局
- 1 To assess the efficacy of Haridradigana Yoga Basti with Haridradigana Ghana Vati over objective parameters ie Blood sugar levels (Fasting and Post Prandial) Urine Sugar level HbA1c in Diabetes Mellitus Type II(2 To assess the efficacy of Metformin over objective parameters ie Blood sugar levels (Fasting and Post Prandial) Urine Sugar level HbA1c in Diabetes Mellitus Type II)