Validation of the therapeutic efficacy of the Siddha herbal formulation Keezhanelli Chooranam (KNC) for managing newly diagnosed patients with Type 2 Diabetes Mellitus (Madhumegam): A proof of concept Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in HbA1c from baseline to 3 months
研究概览
简要总结
This randomized clinical trial aims to evaluate the therapeutic efficacy and safety of Keezhanelli Chooranam (KNC), a traditional Siddha herbal formulation, in managing newly diagnosed patients with Madhumegam (Type 2 Diabetes Mellitus). The primary hypothesis is that KNC can significantly reduce fasting and postprandial blood glucose levels, improve glycemic control, and enhance overall patient well-being when compared to standard care or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Screening glycemic levels: FBS 126–250 mg/dL, PPBS 200–300 mg/dL, HbA1c 6.5–8.0%.
排除标准
- •Type 1 Diabetes Mellitus or Secondary Diabetes Mellitus Cardiovascular and Central Nervous System Disease Diabetes-related complications Pregnant women.
结局指标
主要结局
Change in HbA1c from baseline to 3 months
时间窗: Change in HbA1c from baseline to 3 months | Change in FBS and PPBS from baseline to 3 months
Change in FBS and PPBS from baseline to 3 months
时间窗: Change in HbA1c from baseline to 3 months | Change in FBS and PPBS from baseline to 3 months
次要结局
- Monitoring of adverse events and drug compliance(3 months)
研究者
Dr T Soruban
Siddha Teaching Hospital, Kaithady