A study on the efficacy of tablet Diafyn in Type 2 Diabetes Mellitus – A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Values of FBS PPBS LFT HbA1C will be assessed at the end of the study
研究概览
简要总结
Type 2 Diabetes Mellitus is a metabolic disorder of chronic origin having elevated levels of blood glucose which leads to serious damage of various vital organs specially kidney, eye and nerves. This study was done to evaluate the efficacy and safety of Tablet Diafyn in patients suffering with Type 2 Diabetes Mellitus in achieving the glycemic control. It will be a Randomized Controlled Trial with 2 groups (Interventional arm and control arm), Randomization will be done through computer; allocation concealment and double blinding (investigator and patient) will be followed in the study. Drug compliance will be monitored through home visits by Medical Social Workers. Intervention group will be receiving Tab Diafyn 1gm thrice a day before food and control arm will be receiving Placebo 100% Starch 1 gm thrice a day before food. Starch can increase the blood sugar level, although slowly. Control arm patients also receive standard treatment for diabetes. Following investigations will be done on Day 0 and Day 90:- HbA1c, Fasting and Post Prandial blood sugar, Lipid Profile, B.Urea, S.Creatinine, AST and ALT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed and those subjects on treatment of Type 2 Diabetes Mellitus 2) Age group between 25 to 55 years 3) Glycosylated hemoglobin (HbA1c) between 6.4% to 8.
排除标准
- •Subjects with Type 1 Diabetes Mellitus 2) Subjects with established cases of Alcoholism and Drug abuse 3) Pregnant and lactating women.
- •Subjects with major renal and hepatic disorder.
结局指标
主要结局
Values of FBS PPBS LFT HbA1C will be assessed at the end of the study
时间窗: Baseline and end of 13 weeks.
次要结局
- The safety of the drug will be assessed throughout the study.(Day0,Day90.)