Open labeled, active controlled, randomized evaluation of adjuvent effect of Dhatrinisha Vati in Madhumeha vis- a- vis Diabetes Mellitus type- II
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Assessment of pre and post treatment changes in HbA1c % (Glycosylated Hemoglobin
研究概览
简要总结
This study is an open labeled, active controlled,randomized prospective, clinical study to evaluate the adjuvant effect of DhatriNisha Vati in Type II Diabetic Patients.The drug Dhatri Nisha Vati will be given in a dose of 1 gm Three times in a day orally before meals for 90 days. the conventional antidiabetic medications which patients are taking previously will be continued. The primary outcome measures will be assessment of pre and post treatment changes in HbA1c % (Glycosylated Hemoglobin %) values and monthly assessment of changes in fasting & postprandial plasma glucose levels. The secondary outcomes will be assessment of weight, B.M.I. at baseline and every 30 days upto 90 days, assessment of clinical symptoms of diabetes, assessment of changes in dose of OHAs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •A known diabetic on treatment and a newly diagnosed diabetic.
- •Patients presenting classical symptoms of Madhumeha.
- •Patient with fasting blood sugar up to 220 mg% and post prandial blood sugar up to 300 mg%.
- •Patients having fasting blood sugar in between 221 to 250 and post prandial 301 to 400 and if they are having good, fair, moderate control in HbA1C and normal fundoscopy.
排除标准
- •1.Patients with fasting blood sugar above 220 mg% and post prandial blood sugar above 300mg%.
- •2.Diabetes Mellitus Type-I and those who are under insulin therapy.
- •3.Pregnant and lactating mothers, known cases of Gestational Diabetes.
- •4.Patients with acute complications like Hyperglycemic coma, Ketoacidosis, and infections like gangrene.
- •5.Patients with chronic complications like Nephropathy, Neuropathy and Retinopathy.
- •6.Patients suffering from other diseases such as Tuberculosis, Cardiac diseases, HIV.
结局指标
主要结局
1.Assessment of pre and post treatment changes in HbA1c % (Glycosylated Hemoglobin
时间窗: 1. At base line and at the end of 3 Months. | 2. 0, 30, 60, 90 Days | 3. 0, 30, 60, 90 Days
3. Assessment of efficacy on the basis of subjective parameters
时间窗: 1. At base line and at the end of 3 Months. | 2. 0, 30, 60, 90 Days | 3. 0, 30, 60, 90 Days
%) values.
时间窗: 1. At base line and at the end of 3 Months. | 2. 0, 30, 60, 90 Days | 3. 0, 30, 60, 90 Days
2. Assessment of change in blood sugar fasting and post prandial levels
时间窗: 1. At base line and at the end of 3 Months. | 2. 0, 30, 60, 90 Days | 3. 0, 30, 60, 90 Days
次要结局
- Assessment of change in Body weight(0, 30, 60,90 days)
- Assessment of change in B.M.I(0, 30, 60, 90 Days)