CTRI/2019/08/020946尚未招募2 期
Phase II non-randomized open clinical evaluation of Siddha Drug "Naga Chendhooram" for Madhumegam (Type 2 Diabetes Mellitus)- in patients of both gender between age group of 30 to 60 years, attending OPD at AAGHIM attached with GSMC
Government Siddha Medical College1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年4月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction in clinical symptoms
研究概览
简要总结
This is a Non randomised open clinical trial to study the safety and efficacy of siddha drug "Naga Chendhooram". Drug is given 100 mg twice a day for 90 days. Clinical trial is conducted after completion of preclinical toxicity studies. The said drug "Naga Chendhooram" has reference in "Siddha Formulary of india" - part1 . During the study, all the related data will be recorded and documented.
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)（—）
- 性别
- All
入选标准
- •Mandatory Fasting blood glucose-120 to 160 mg/do PP blood glucose- 180 to 280 mg/DL HbA1c- 6.5 to 9% Optional Polyuria Polyphagia Polydipsia Nocturia.
排除标准
- •Insulin dependent Diabetes mellitus Cardiovascular disease Diabetic nephropathy Diabetic retinopathy Pregnant women Lactating mothers Tuberculosis affected individuals HbA1c > 9%.
结局指标
主要结局
Reduction in clinical symptoms
时间窗: 90 days
Reduction in blood sugar and HbA1c level by atleast 20% or to maintain HbA1c level within 7%
时间窗: 90 days
次要结局
- Secondary outcome is assessed by comparing the safety parameters before and after treatment(90 days)
研究者
研究点 (1)
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