CTRI/2022/04/042211已完成4 期
Post Marketing Clinical Trial to Evaluate the Safety & Efficacy of Cannaease Vijaya Tinctures(Sleep Well 10%)
Ananta Hempworks Solutions Pvt Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Provide informed consent prior to any study specific assessments being performed
- •2.Between 18 and 60 years old, inclusively
- •3.Insomnia as defined by an ISI score of 8 or above
- •4.Insomnia symptoms for at least 3 months or less than 6.5 hours of sleep per night
- •5. Resident of India and currently living in the India for the duration of the trial
排除标准
- •1. Presence of an active and progressive physical illness (e.g.,
- •congestive-heart failure, chronic obstructive pulmonary
- •disease, acute pain), neurological disorder (e.g., epilepsy) or
- •neurological degenerative diseases (e.g., dementia, multiple
- •2. Unstable medication regimen (change to schedule or dosage
- •within the past 3 months)
- •3. Diagnosis of a psychotic disorder or bipolar disorder or
- •medical condition contraindicated by sleep restriction
- •4. Have family or work schedules that prevent them from having
- •normal sleep schedules defined as bedtime between 8:00 pm
- •and 2:00 am and/or waking times between 4:00 am and 10:00
- •5. Individuals who need to be alert or cautious to avoid serious
- •accidents in their job or daily life. Examples include: Long-
- •haul truck drivers, Long-distance bus drivers, Air traffic
- •controllers, Operators of heavy machinery, some assembly line
- •6. Pregnant or planning to become pregnant during the course of
- •7. Other untreated sleep disorders as self-reported by the
- •participant (e.g., obstructive sleep apnea, periodic leg
- •movements, parasomnias)
- •8. Participated in an investigational research study in the past 30
研究者
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