CTRI/2022/11/047116暂停3 期
An Open Label, Single arm, prospective, Clinical study to evaluate efficacy and safety of Diabosudha Tablet and Diabosudha Liquid in Subjects with Mild to Moderate Diabetes Mellites Type 2.
Sahyadri Ayurvedic Life Pvt. Ltd.0 个研究点目标入组 1 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 1
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. Gender: Either male or non-pregnant, non-lactating female aged > 18-70 < years (both inclusive).
- •2. Type 2 diabetes subjects (diagnosed clinically) = 6 months prior to screening.
- •3. HbA1c = 7.0 % and = 10.0 % (both inclusive).
- •4. Subjects willing to give written informed consent.
- •5. Subjects able to comply with the study protocol.
- •6. Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
- •7. Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
排除标准
- •1. Suspected or confirmed pregnancy.
- •2. Diagnosis of any known chronic or acute medical disease of any kind (e.g., cardiovascular disease, respiratory disease, influenza, pneumonia, etc.)
- •3. Diagnosis of any known neurological disease or psychological disorder of any kind (e.g., brain lesion, epilepsy, anxiety, eating disorder, mood disorder, sleep disorder, etc.)
- •4. Any implanted electrical medical device (e.g., pacemaker, insulin pump, deep brain stimulator, etc.)
- •5. Any form of prescription medication.
- •6. Use of antibiotics in the three months prior to enrolment.
- •7. A direct or familiar relationship with the Sponsor, Investigator, or site personnel affiliated with the study.
研究者
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