An open label, single arm clinical study on the combined effectiveness of Lodhradi Kashaya And Navaka Guggulu In Madumeha (Type 2 Diabetes Mellitus)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- polydipsia
研究概览
简要总结
In this present generation the sedentary life style, lack of exercise, stress, life style modifications, change in dietary habits, urbanization precipitate the disease of Santarpanjanya vyadhis like as Prameha 1. It told as one of the astamahaagadas 2, Madhumeha is a Vataja Prameha 3 .Prameha is characterized by Prabhutha mutratva and Avila mutratva 4 The clinical feature like Madhura asyata , karapadadaha, suptata, mukha talu kanthashosha, pipasa-adhikya, alasya, tandra 5 can be correlated to the features ofType 2 Diabetes Mellitus.Diabetes Mellitus Type 2 and its complications pose a major threat to public health resource throughout the world. In today’s era, Type 2 Diabetes Mellitus has gained gigantic disgrace in recent times as it is fast becoming the world’s largest silent killer. In 2021, Approximately 537 million adults (20-79 years) are living with Type 2 Diabetes Mellitus.The total number of people living with diabetes Type 2 is projected to rise to 643 million by 2030 and 783 million by 20456. It has become utmost importance to find ways to combat this disease. Adults with Type 2 Diabetes Mellitus have a two-threefold increased risk of heart attacks and strokes. Diabetes is the cause of 2.6% of global blindness and it’s also a leading causes of kidney failure 7.
With an increasing incidence worldwide and due to chronic complications, there is need for effective management of Type 2 Diabetes mellitus. Ingredients of Lodhradi Kashaya possess tikta kashaya rasa, laghu guna, katu vipaka,pramehagna karma and Navaka guggulu possess katu tikta rasa, laghu ,rooksha guna,kapha vatahara, medohara ,amapachana karma. As madumeha is santarparnajanya vyadhi. K**apha and vata is main dosha and meda is main dushya involved in the manifestation of vyadhi. These formulations may help to act against it. The ingredients of both formulations are safe and easily available. This study is intended to evaluate the effectiveness of this combination in madhumeha .
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 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
- •1.Subjects above 30 years up to 70 years of either gender suffering from Type 2 Diabetes Mellitus under control will be taken.
- •2.Fasting blood sugar ≥ 126 mg/dL.
- •3.Post prandial blood sugar (PPBS) level ≥180 mg/dL.
- •4.Those patients willing to participate in the study and who are ready to sign the informed.
排除标准
- •1.Subjects of Type 2 Diabetes Mellitus on insulin 2.Subjects of Type 2 Diabetes Mellitus with HbA1c >10%, FBS >250 mg/dl, PPBS >350mg/dl 3.Subjects with known case of cardiac illness, impaired kidney and liver function 4.Pregnant women and lactating mother.
结局指标
主要结局
polydipsia
时间窗: 30
karapada daha
时间窗: 30
karapada suptata
时间窗: 30
polyurea
时间窗: 30
polyphagaia
时间窗: 30
angasaada
时间窗: 30
次要结局
- Fasting blood glucose & Post prandial blood glucose- Before & after treatment (1st day & 31st day)(30 days)
