Open Labeled Randomized Controlled Clinical Trial on Impaired Glucose Tolerance – IGT (MUNNEERIZHUVU)
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
- During treatment or after treatment OGTT 2 hours result is less than 140 mg/dl, fasting blood sugar is lessthan 100 mg/dl and HbA1c is lessthan or equal to 6.0 % it will be treated as successful outcome of the treatment.
研究概览
简要总结
This study is a Open Labeled Randomized Controlled Clinical Trial to assess the efficacy of Tablet Thiriphala chooranam 500mg, 4 for twice a day for 180 days in 60 patients with Impaired Glucose Tolerance- IGT(Munnerizhivu). It is Open labeled and Double arm study. The primary outcome is during treatment or after treatment OGTT 2 hours result is less than 140 mg/dl, fasting blood sugar is lessthan 100 mg/dl and HbA1c is lessthan or equal to 6.0 % it will be treated as successful outcome of the treatment. The time limit is 180 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Males or Females with a diagnosis of Impaired Glucose Tolerance (Munnerizhivu).
- •IGT defined as those patients with Fasting glucose levels -- above 100 mg/dl to within or equal to 125 mg/dl After 2 hour OGTT -- within 140 mg/dl to 199 mg/dl Glycated hemoglobin (HbA1C)-- Above 6.0% to within 6.5%.
排除标准
- •Subjects with the age below 30 and above 60 years known Diabetes, Malignant and accelerated hypertensive, Chronic Liver and Renal diseases, Coronary artery disease, Secondary Diabetes mellitus, CNS disorder (e.g. encephalopathy) Patient undergoing regular treatment for any other severe illness Pregnant woman and planning to be pregnant within six months and lactating mother.
结局指标
主要结局
During treatment or after treatment OGTT 2 hours result is less than 140 mg/dl, fasting blood sugar is lessthan 100 mg/dl and HbA1c is lessthan or equal to 6.0 % it will be treated as successful outcome of the treatment.
时间窗: 180 Days
次要结局
- Normal Liver function test and renal function test should be taken as success end point towards safety.(180 Days)