Phase II non randomized open clinical evaluation of Siddha medicine Seenthil Chooranam for the management of Madhumegam (Type II Diabetes Mellitus)
试验速览
- 阶段
- 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
- Reduction in HbA1C level (at least 20%)
研究概览
简要总结
Diabetesmellitus is a clinical syndrome characterised by increase in plasma bloodglucose (Hyperglycemia). There are two types of diabetes mellitus ,Type I andType II. Type I Diabetes Mellitus is caused by autoimmune destruction of betacells in the pancreas, resulting in absolute insulin deficiency, whereas TypeI Diabetes Mellitus is due to insulin deficiency or defective actionof insulin or both.Chronic hyperglycemia is responsible fordiabetes specific microvascular complications affecting the eyes (retinopathy),kidneys (nephropathy) and feet (neuropathy).
Indiais deemed as the world’s capital of Diabetes. In 2021, approximately 537million adults (20-79years of age ) are living with diabetes. The total numberof people living with diabetes is projected to rise to 643 million by 2030 and783 million by 2045.The diabetic population in the country close to hitting thealarming mark of 69.9 million by2030.
Theclassical siddha medicine formulation **“SEENTHIL CHOORANAMâ€**mentionedin **"The Siddha Formulary of India-Part I ".**isindicated for Madhumegam (Diabetes mellitus). Moreover this formulation hasanti-diabetic activity that had been proven scientifically .So the authortries to evaluate its efficacy in the management of Type II DiabetesMellitus)in a non-randomised open clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)(—)
入选标准
- •1 Sex: All Gender 2 Polyuria 3 Polyphagia 4 Polydipsia 5 Nocturia 6 HbA1C.
排除标准
- •1 Pregnant women 2 Lactating mothers 3 Insulin dependent Diabetes mellitus 4 Cardiovascular disease 5 Diabetic nephropathy 6 Diabetic retinopathy • Recently diagnosed patient with tuberculosis • HbA1c > 9% The above criteria will be excluded clinically or based on the available medical reports.
结局指标
主要结局
Reduction in HbA1C level (at least 20%)
时间窗: 90 Days
次要结局
- Reduction in clinical symptoms like Polyuria,Polydipsia,Polyphagia & Fatigue.(90 Days)
