CTRI/2023/12/060756尚未招募3 期
Evaluation of Comparative efficacy of Ashwagandha (Withania Somnifera) Vs Brahmi (Bacopa monnieri Linn) on stress level and quality of sleep in subjects experiencing stress.
Dr Mohnish Gokhale1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Lowering of stress level in patients of stress level in subjects experiencing stress
研究概览
简要总结
This study is Double blind randomised controlled trial comparing theclinical efficacy of Tablet Ashwagandha 500 gm HS and Tablet Brahmi 500 mg HS for 60 days in 60 patients(30 patients in each group) the primaryoutcome will measure by Percieved stress scale (PSS) Montreal Cognitive assesment test Pittersberg sleep quality index (PSQI) before and after completion of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Body mass index 18–29 kg/m2 2 Healthy as determined by medical history physical examination, and clinical judgment of the investigator under perceived stress with a score of 14–24 on the PSS 3 Cognitively sound as confirmed by the Montreal Cognitive Assessment test 4 Willing and able to provide written informed consent and agreed to attend regular follow-ups 5 Patients with controlled NIDDM & HTN.
排除标准
- •1 Pregnant & lactating woman 2 Subjects with an education level below the eighth grade and unable to read 3 Subjects with any severe comorbid medical conditions or any clinically significant systemic disease with significant medication use 4 Subjects with a history of drug dependence alcohol intake or having nicotine or caffeine dependence 5 Night duty people.
结局指标
主要结局
Lowering of stress level in patients of stress level in subjects experiencing stress
时间窗: 60 Days
次要结局
- Improving of sleep quality(60 Days)
研究者
研究点 (1)
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