CTRI/2020/06/026007尚未招募4 期
Evaluation of Efficacy and safety of Gamma-oryzanol in Type-2 diabetes: a Randomized Double Blind Placebo Controlled trial
AP Organics0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
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
- •i. Type-2 DM <5 years duration
- •ii. On stable oral hypoglycaemic agents
- •Metformin ± Sulfonylurea)
- •iii. No change in anti-diabetic
- •treatment for the last 3 months.
- •iv. HbA1c <7.5%
- •v. Fasting plasma glucose not exceeding 180mg/dL
- •vi. Patients with Negative Urine sugar
排除标准
- •i. Diabetes other than type 2 diabetes mellitus
- •ii. Evidence of renal disease (S. Creatinine >
- •iii. Evidence of liver disease (AST/ALT >3 times
- •iv. Pregnant and lactating mothers and women
- •intending pregnancy
- •v. Participation in any other clinical trial with
- •in the last 30 days
- •vi. History of any hemoglobinopathy that may affect
- •determination of Glycosylated Haemoglobin
- •vii. Treatment with oral anti-diabetic agents (other
- •than Metformin or SU) during the 12 weeks
- •before baseline visit.
- •viii. History of intolerance or hypersensitivity to
- •sulfonylurea or Metformin or Gamma-oryzanol.
- •ix. Any condition which in the opinion of the PI
- •that is significant and can make the patient
- •unsuitable for study or can place it under
- •additional risk, such as intolerance, allergy
- •to Gamma-oryzanol.
研究者
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