Randomized Controlled Clinical study on the efficacy of Vidangadi Lauha on Sthula Madhumeha with special reference to Type II Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 3. To compare the effect of drug in Trial Group Vidangadi Lauha with that of drug in Control Group Tablet Metformin 500mg.
研究概览
简要总结
Diabetes Mellitus is a major public health challenge of the twenty-first century. Increasing Levels of Urbanization, Industrialization and economic advancement adversely affect the biological and environmental risk factors for Diabetes and other non-communicable diseases. Unhealthy diet, physical inactivity and stress factors cause overweight and insulin resistance1. This study entitled “Randomised Controlled Clinical Study on the Efficacy of Vidangadi Lauha on Sthula Madhumeha with special reference to Type II Diabetes Mellitus."
All the parameters of assessment will be based on the signs and symptoms of Prameha mentioned in classics and the diagnostic criteria. Patients fulfilling the criteria will be selected and divided in two groups called trial and control group followed by a filling of consent form in language best understood by them. Control group patients will be administered by tab Metformin in a dose of 500 mg twice a day while in trial group patients will be going to manage with Vidangadi Lauha as above mentioned dose and timing.
All the parameters will be assessed before and after treatment based on the specially prepared proforma, Appropriate test will be applied to the data outcome and discussion and conclusion will be made accordingly.Appropriate test will be applied to the data outcome and discussion and conclusion will be made accordingly.
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
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly detected patients having fasting blood sugar level more than 126mg/dl and post prandial blood sugar level more than 200mg/dl (A.D.A 2015)
- •Newly detected patients fulfilling criteria of diagnosis and having signs and symptoms of Sthula Madhumeha (Diabetes Mellitus)
- •Patients having age between 30 to 70 years
- •HbA1c up to 9%
- •Patients having BMI more than 23 will be selected up to 30 (chamukuttan.s.2006)
- •Those are willing to participate in trial and ready to give written consent.
- •Patients with controlled Hypertension.
排除标准
- •Patients having age below 30 and above
- •Patients with fasting blood sugar level >200mg/dl and post meal blood sugar level>300mg/dl.
- •HbA1c more than 9%.
- •Patients having BMI less than 23 and above
- •Patients who already taken anti Diabetic drugs
- •Patients having insulin dependent diabetes mellitus and juvenile diabetes
- •Patients having complications such as vasculopathy, nephropathy, retinopathy and neuropathy.
- •Those are not willing to participate in trial and not ready to give written consent.
- •Patients having other systemic complications like hepatic, renal and cardiac problems.
- •If any complication arises during treatment or if any patient discontinues the treatment these cases will be liable for rejection.
- •12 .Pregnant and lactating females not included in this study.
- •Emergency cases in Type 2 Diabetes Mellitus.
结局指标
主要结局
3. To compare the effect of drug in Trial Group Vidangadi Lauha with that of drug in Control Group Tablet Metformin 500mg.
时间窗: 1)On zero day assessments i. e. B.T. value | 2)For Trial group Vidangadi Lauha 5 gm BD before meal for 3 month | 3)For Control Group Tab. Metformin 500 mg BD before meal for 3 months | 4)Follow up assessment will be done on 31rst ,61rst, day and Data will be analyzed statisticaly. | 5)Final assessment will be done on 91rst day and statistical analysis will be done.
1. To evaluate the effect of Vidangadi Lauha on clinical features of Sthula Madhumeha ,blood sugar level,B.M.I. and hip waist ratio(Type II Diabetes Mellitus) and specifically on its parameters
时间窗: 1)On zero day assessments i. e. B.T. value | 2)For Trial group Vidangadi Lauha 5 gm BD before meal for 3 month | 3)For Control Group Tab. Metformin 500 mg BD before meal for 3 months | 4)Follow up assessment will be done on 31rst ,61rst, day and Data will be analyzed statisticaly. | 5)Final assessment will be done on 91rst day and statistical analysis will be done.
2. To evaluate the effect of Tab metformin on clinical features of Sthula Madhumeha (Type II Diabetes Mellitus) and specifically on its Parameters.
时间窗: 1)On zero day assessments i. e. B.T. value | 2)For Trial group Vidangadi Lauha 5 gm BD before meal for 3 month | 3)For Control Group Tab. Metformin 500 mg BD before meal for 3 months | 4)Follow up assessment will be done on 31rst ,61rst, day and Data will be analyzed statisticaly. | 5)Final assessment will be done on 91rst day and statistical analysis will be done.
次要结局
- 1. To study the literature of Madhumeha as per Ayurvedic perspective.(2. To study Madhumeha which is correlated with type 2 Diabetes mellitus with modern point of view.)