NCT05821049已完成不适用
A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy of UP165 on Sleep Quality and Mood State in Healthy Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 12
- 主要终点
- To assess the efficacy of the Investigational Product (IP) from baseline on
研究概览
简要总结
A randomized, double blind, placebo controlled, parallel group study to evaluate the efficacy of UP165 on sleep quality and mood state in healthy adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Envelope Blinding Chits
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects ≥20 and ≤ 60 years' old with moderate physical activity level as per International Physical Activity Questionnaire - Short Form(IPAQ - SF)
- •Volunteers with body mass index between 18.5 and 29.9 kg/m
- •Fairly bad or very bad subjective sleep quality with a score of 2 or 3 assessed as per PSQI Q
- •Willing to maintain current dietary pattern, activity level, and stable bodyweight for the duration of the study, and refrain from any drastic lifestyle changes.
- •Unable to fall asleep or unable to stay asleep (2 or more waking episodes during sleep at least twice a week but not more than four times)
- •Agrees to maintain current sleep schedule throughout the study
- •Agrees to stay in the current time zone for the duration of the study
- •Subjects ready to give voluntary, written, informed consent to participate in the study.
- •Willing to complete all study procedures including study-related questionnaires and comply with study requirements.
排除标准
- •Subjects diagnosed with sleep disorders secondary to another health problem.
- •Consumption of hypnotic drugs (<3 months before inclusion).
- •Subjects with a history of caffeine consumption post 6:00 pm.
- •Individuals taking any other sleep supplements and are unwilling to stop taking those supplements for the duration of the study period
- •Recent history of physical, emotional, social trauma within last three months.
- •Participants who are not medication (which are likely to impact sleep quality or pattern) free for at least 4 weeks apart from contraceptive pills
- •Subjects who consume pain-relieving medications more than once per week.
- •Individuals who have night terrors regularly
- •Individuals who regularly sleepwalk
- •Individuals who work at night shifts.
- •Individuals who have regular bad dreams
- •Use of the following medications during the study period: oral or injectable corticosteroid, sedating antihistamines (e.g. cold, allergy, motion sickness), psychotropic medications or hypnotics, benzodiazepine, narcotics, any illicit drugs
- •Gastro-intestinal, hepatic, respiratory, psychiatric, kidney, or cardiovascular disorder (<3 months before inclusion),
- •Recent (<3 months before inclusion) change in lifestyle (food, body weight, sport, drug, and/or dietary supplement),
- •Students having regular class and assignments
- •Subjects addicted to digital media who exhibit at least five of the following symptoms currently:
- •i) Preoccupation with the digital media use j) Withdrawal symptoms that occur when digital media use is not possible k) Build-up of a tolerance that requires increasing amounts of digital media use to satisfy cravings l) Unsuccessful attempts to stop or limit digital media use m) Replacement of previously pleasurable activities with digital media use n) Unwillingness to stop digital media use despite its negative consequences o) Being deceptive about digital media use p) Using digital media use as a coping mechanism
- •Addiction or history of substance abuse,
- •Consumption of more than 3 glasses of alcohol per day,
- •Pregnant or lactating woman,
- •Lifestyle habits which would modify the wake-sleep rhythm, or which was expected to be modified during the study period (e.g., night work), and finally,
- •Known allergy to the IP.
结局指标
主要结局
To assess the efficacy of the Investigational Product (IP) from baseline on
时间窗: Day 7
The change in sleep index through the global scores of the Pittsburgh Sleep Quality Index (PSQI)
次要结局
未报告次要终点
研究者
研究点 (12)
Loading locations...
相似试验
已完成
1 期
ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM)Type 2 DiabetesNCT05134662Altimmune, Inc.55
已完成
1 期
To Evaluate the Safety, Tolerability and PK of GT20029 Gel and Solution in Healthy SubjectsAlopeciaAcneNCT06468579Suzhou Kintor Pharmaceutical Inc,92
已完成
不适用
Investigating the Efficacy of Brain Octane® Oil on Cognition, Coordination, Reaction Time and Measurements of Physical Performance in Recreationally Active AdultsHealthyNCT04095728Bulletproof 360, Inc.30
已完成
1 期
A Study of Lebrikizumab in Healthy Japanese and Caucasian VolunteersHealthy VolunteerNCT01423318Genentech, Inc.60
已完成
1 期
A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian VolunteersDry Eye SyndromesNCT04104997GL Pharm Tech Corporation39