Add On Efficacy Of Nishakatakadi Kashayam Capsule In Type 2 Diabetes Mellitus A Randomized Double Blind Placebo Controlled Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
研究概览
简要总结
Type 2 Diabetes Mellitus is a metabolic disorder that occurs due to reduced response of body cells to insulin and a gradual decline in insulin secretion. It leads to high blood sugar levels and long term complications affecting the eyes, kidneys, nerves and heart. Although many modern medicines are available, they may cause side effects and do not always provide optimal control. Yoga, diet and Ayurveda based integrated approaches have shown helpful effects in earlier studies. However, there is limited scientific evidence on the independent effect of Ayurveda drugs used alone in Type 2 Diabetes. This study aims to evaluate the effectiveness of an Ayurveda drug as a standalone treatment in patients with Type 2 Diabetes Mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Known subject of Type 2 Diabetes mellitus having HbA1c more than 6.5% with established clinical diagnosis of Type 2 Diabetes mellitus for at least 3 months prior to screening period and are on standard diabetic care Both gender of Age group between 20 to 70 years Subject with a normal serum creatinine level less than 1.5 mg /dl Subject who submits written informed consent.
排除标准
- •Subjects with Type 1 Diabetes Mellitus.
- •Subjects being treated for Type 2 Diabetes Mellitus with insulin.
- •Subjects with established diagnosis of CAD or any other clinically significant cardiovascular disease.
- •Uncontrolled hypertension.
- •Subjects with established cases of cerebrovascular accidents such as stroke etc.
- •Subjects with any complications of Type 2 Diabetes Mellitus such as retinopathy, neuropathy, nephropathy etc.
- •Pregnant and lactating women.
- •Subjects with evidence of malignancy.
研究者
Dr Bhivate Sneha Sanjay
KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi