CTRI/2023/04/051364已完成Unknown
A randomized, double blind, placebo controlled, parallel group study to evaluate the efficacy of UP165 on sleep quality and mood state in healthy adults
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 175
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
- •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/m2.
- •Fairly bad or very bad subjective sleep quality with a score of 2 or 3 assessed as per PSQI Q9.
- •Willing to maintain current dietary pattern, activity level, and stable body weight 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.
研究者
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