CTRI/2017/04/008288尚未招募未知
A Multicenter, Open Label, Randomized, Parallel Group Clinical Study Designed To Examine The Efficacy And Safety Of TLY-001 In Both Kashayam And Kashayam Tablet Form Twice Daily Oral Dose In 150 Patients With Newly Diagnosed Type 2 Diabetes Mellitus Over A Period Of Ninety (90) Days.
Clinfound Clinical Research Services PvtLtd0 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients with FBS >= 130 mg/dl to <= 250 mg/dl.
- •2.Patients with BMI Ë? 45 kg/m2 .
- •3.Newly detected Type 2 Diabetes Mellitus (not more than 1 year).
- •4.The patient with the ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •5.Patients willing to comply with protocol requirements
排除标准
- •1.Patients with Type 1 Diabetes or secondary form of Diabetes
- •2.Pregnant, breast feeding, or planning a pregnancy.
- •3.Patient with history of treatment with Insulin
- •4.Patient with history of treatment with any antihyperglycaemic agent.
- •5.Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, GI tract, or central nervous system.
- •6.Known to have AIDS or HIV positive.
研究者
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