A Randomized Standard Controlled Clinical trial to evaluate an add on effect of Katakakhadiradi kashay Ghan vati with oral Hypoglycemic drug in Prameha
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To evaluate an efficacy of katakakhadiradi Ghan Vati 500mg twice a day before meal with koshnajala for 3 months as an add on effect to oral hypoglycemic agent in Prameha.
研究概览
简要总结
Prameha which is known to world as Diabetes, is a global health problem and receiving much attention now-a-days. Prameha is can be correlated with classical metabolic disorder.
Acharya Charaka has described following Hetus for Prameha like Aasya sukh, Swapna sukh, Dadhini, Gramya-Audak-Anupa-Rasa intake of meat of pet animals .
All above hetus cause vitiation of all doshas with increased in Kleda which leads to Dhatwagni mandya.
All contains of trial drug has properties like Kledghna, Medodushti Ghan, Rasayan, Kaphghna, Medodhatwagni vardhan properties.
Hence this combination possesses all propertioes of potent medicine useful for Prameha chikitsa.
To evaluate an add on effect of Katakkhadiradi Kashay Ghan Vati in Prameha with Oral Hypoglycemic Agent this study designed.
Therefore, this formulation was choosen for present study.
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.Sign and symptoms of Prameha 2.known case of Type-2 DM, NIDDM 3.Patient having HbA1C upto-10 4.Fasting blood sugar upto 250 mg% and post prandial blood sugar upto 350 mg% 5.patient taking Metformin+Glimepride drug since min 6 months.
排除标准
- •1.Juvenile Diabetes and Insulin Dependent Diabetes Mellitus (IDDM).
- •2.Patients with CKD and AKD.
- •3.Patients with acute complications Hyperglycemic & hypoglycemic coma,Ketoacidosis and related complication and Infections like gangrene.
- •4.Patients with chronic diabetic complications Nephropathy, Neuropathy and Retinopathy.
- •5.Pregnant & lactating women.
- •6.Patients suffering from all major systemic diseases IHD, TB, CA.
结局指标
主要结局
To evaluate an efficacy of katakakhadiradi Ghan Vati 500mg twice a day before meal with koshnajala for 3 months as an add on effect to oral hypoglycemic agent in Prameha.
时间窗: 90 days with follow up on 15th,30th,45th,60th,75th,90th day
次要结局
- 1.To compare and study the efficacy of Katakakhadiradi Ghan Vati for 3 months.(2.To compare and study the efficacy of oral hypoglycemic agent for 3 months.)