In Vivo and Randomized Control Trial of Daruharidradi Ghanavati in Sthula Madhumeha with specific reference to Type II Diabetes Mellitus
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. To study the effect of Daruharidradi Ghanavati in Streptozotocin induced diabetes Mellitus in Wister rats specifically on blood sugar level.
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 “In Vivo and Randomized Control Trial of Daruharidradi Ghanavati in Sthula Madhumeha with specific reference to Type II Diabetes Mellitusâ€
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 Daruharidradi Ghanavati 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.
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
- •The patients having fasting plasma sugar level more than or equal to 126mg/dl and post prandial plasma sugar level more than or equal to 200mg/dl (A.D.A 2016)
- •The patients fulfilling criteria of diagnosis and having clinical features of Sthula Madhumeha (Diabetes Mellitus)
- •Patients having BMI more than 23Kg/m2 up to 30Kg/m2 will be selected.
- •HbA1c is 6.5%up to 10%.
- •Patients having age between 30years to 70 years.
- •Those are willing to participate in trial and ready to give their written consent.
排除标准
- •Patients who already taking anti-diabetic drugs.
- •Patients with fasting plasma sugar level >250mg/dl and post meal plasma sugar level >350mg/dl.
- •Patients having insulin dependent diabetes mellitus and juvenile diabetes and various other types of diabetes except Type II DM.
- •4.Patients having BMI less than 23kg/m2 and More Than 30kg/m
- •HbA1c more than 10%.
- •Patients having age below 30 years and above 70 years.
- •Patients having other systemic complications like hepatic, renal and cardiac problems.
- •Patients having poorly controlled blood pressure.
- •Pregnant and lactating females not included in this study.
结局指标
主要结局
1. To study the effect of Daruharidradi Ghanavati in Streptozotocin induced diabetes Mellitus in Wister rats specifically on blood sugar level.
时间窗: 1.In Animal study-In Rats anti diabetic effect will be assessed after one month.. | In Clinical trial - | 1.On zero day i.e. before treatment value. | 2.In trial group Daruharidradi Ghan Vati 500mg twice a day and in control group tablet Metformin 500mg twice a day will be given for 3months. | 3.Follow up and assessment will be done on every 15days after starting medicine up to 90 days. | 4.Final assessment will be done on ninety first day.
2.To study the effect of Daruharidradi Ghanavati on Sthula Madhumeha with specific reference to type II diabetes mellitus, on fasting and post prandial plasma sugar level and HbA1c,and to compare its effect with metformin.
时间窗: 1.In Animal study-In Rats anti diabetic effect will be assessed after one month.. | In Clinical trial - | 1.On zero day i.e. before treatment value. | 2.In trial group Daruharidradi Ghan Vati 500mg twice a day and in control group tablet Metformin 500mg twice a day will be given for 3months. | 3.Follow up and assessment will be done on every 15days after starting medicine up to 90 days. | 4.Final assessment will be done on ninety first day.
次要结局
- 1. To study the toxic effects of Daruharidradi Ghanavati by investigating LFT, KFT and relevant histo-pathological investigations in Swiss Albino mice.(2. To study the literature of Madhumeha as per Ayurvedic perspective. 3. To study the literature of Diabetes Mellitus.)