CTRI/2023/10/058467尚未招募3 期
An open-labeled, single-arm, interventional clinical study to evaluate safety and efficacy of a botanical containing tablet (CAG-11) in the management of Stress
Amway Global Services India Pvt. Ltd.0 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
- 3 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
- •1. Men and women aged between 18-50 years, both inclusive.
- •2. Subjects presenting continuous stress related problems for more than 2 weeks
- •3. Subjects not under treatment for stress in the last 2 weeks of screening
- •4. Subjects presenting moderate continuous stress levels basis PSS scale between 14 - 26
- •5. Able and willing to follow all study related instructions.
- •6. Must be willing to give written informed consent and comply with the study procedures.
- •7. Subject’s complete blood count parameters to be within clinically acceptable range by Investigator.
排除标准
- •1. Pregnant and Breast-feeding women will be excluded.
- •2. On-going treatment on managing stress levels.
- •3. Severe psychiatric disorders, severe episodes of anxiety disorders, post-traumatic stress disorder
- •4. Subjects presenting with severe continuous stress levels basis PSS scale (27 – 40)
- •5. Systemic disorders, who have undergone surgeries, are on medications, endocrinal disorders
- •6. History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months
- •7. Any condition that in the opinion of the investigator does not justify the subject’s inclusion for the study.
- •8. Subjects with underlying heart conditions, other lifestyle disorders and systemic illness.
研究者
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