CTRI/2020/03/024195尚未招募1/2 期
A Randomized Controlled clinical study to evaluate an adjuvant effect of Nishakatkadi Ghan vati with oral Hypoglycemic agent in diabetes Mellitus (type2)
Principal PDEAs college of Ayurved and Research centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月4日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate efficacy of Nishakatkadi Ghan Vati 500mg three times before breakfast,lunch and dinner a day for 3 months as an adjuvant medication to oral hypoglycemic agent in the management of diabetes mellitus type 2on basis of BSL and HbA1C values
研究概览
简要总结
prameha is disease well known sine vedic period.prameha,which is known to world as diabetes,is global helth problems,it is metabolic disorder, which includes sign and symptoms of prabhutavilmutrata,daurbalya,kshudhavruddhi pipasaadhikya.etc nishakathkadi ghanvati in mentioned in shahasrayogum,drugs is havingantihyperglycemic effect,antilipidemic action,kledhagna,kafgna properties
hence this drug will be used in DM2.
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
- 35.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age group between 35 years to 70 years 2.cases of both gender will be included 3.patient with fasting blood sugar upto 200 mg% and post parandial blood sugar 300mg%.
排除标准
- •1.insulin dependent diabetes mellitus (IDDM)and those who are under insulin therapy.
- •2.patient with acute complications like hyperglycemic and hypoglycemic coma,ketoacidosis and related complication and infections like gangrene.
- •3.patient with chronic diabetic complications like Nephropathy,Neuropathy and Retinopathy.
- •4.pregnant and lactating woman.
- •5.patients suffering from all major systemic diseases.
结局指标
主要结局
To evaluate efficacy of Nishakatkadi Ghan Vati 500mg three times before breakfast,lunch and dinner a day for 3 months as an adjuvant medication to oral hypoglycemic agent in the management of diabetes mellitus type 2on basis of BSL and HbA1C values
时间窗: 90 Days with follow up on every 15th day
次要结局
- 1.to study the effect of Nishakatkadi Ghan vati 90days.(2.to study the effect of oral Hypoglyacemic agent.)
研究者
研究点 (1)
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