KCT0012330招募中不适用
A 4-week, randomized, double-blind, placebo-controlled cross-over clinical trial to evaluate the efficacy and safety of Perilla frutescens and peppermint extract complex on sleep health improvement
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 主要目的
- Other(To evaluate the efficacy and safety of Perilla frutescens and peppermint extract complex on sleep improvement), Intervention Model : Cross-over, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Allocation : RCT
入排标准
- 年龄范围
- 19(Year) 至 64(Year)（—）
- 性别
- All
入选标准
- •Men and women aged 19 to under 65 years old at the time of screening.
- •Individuals who experience one or more of the following symptoms at least once per week: difficulty initiating or maintaining sleep, early morning awakening with an inability to return to sleep, or non-restorative sleep (feeling unrefreshed despite sleeping).
- •Individuals with a total score >5 on the Pittsburgh Sleep Quality Index (PSQI), indicating poor sleep quality.
- •Individuals who voluntarily provide written informed consent to participate in this study and are able to understand and comply with the study procedures and requirements.
排除标准
- •Individuals who, based on an assessment using a structured diagnostic instrument, have major depressive disorder, bipolar disorder, alcohol dependence, or schizophrenia requiring treatment.
- •Individuals with an Insomnia Severity Index (ISI) total score of 22 or higher, indicating severe insomnia.
- •Individuals with an Epworth Sleepiness Scale (ESS) total score of 16 or higher, indicating severe daytime sleepiness.
- •Individuals who are currently receiving treatment for, or require treatment for, any of the following conditions that may cause sleep disturbances: sleep apnea, restless legs syndrome, periodic limb movement disorder, or narcolepsy.
- •Individuals with a body mass index (BMI) of 18.5 kg/m² or lower or 30 kg/m² or higher.
- •Individuals with medical conditions that are not adequately controlled with medication, such as hypertension, diabetes mellitus, thyroid dysfunction, or renal failure.
- •Individuals with a history of traumatic brain injury accompanied by loss of consciousness or seizures.
- •Individuals currently taking medications known to commonly cause sleep disturbances.
- •Individuals who have taken sleeping pills, tranquilizers, psychotropic medications, herbal medicines, or health functional foods that may affect sleep within 1 month before the screening visit.
- •Individuals who are unable to undergo brain magnetic resonance imaging (MRI) or polysomnography (PSG), including those with claustrophobia or implanted metallic medical devices.
- •Individuals who work night shifts or have irregular habitual bedtimes because of their occupation or for other reasons.
- •Individuals who have traveled long distances across time zones within 1 month before the screening visit.
- •Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period.
- •Individuals whose average daily caffeine intake exceeds 300 mg/day, equivalent to approximately three cups of Americano coffee or five cups of instant coffee mix.
- •Individuals who have continuously consumed any ingredient contained in the test product for one month or longer.
- •Individuals with hypersensitivity, allergies, or adverse reactions to any ingredient contained in the test product or control product.
- •Individuals who have participated in other clinical trials (including human trials) within 1 month before the screening visit or who plan to participate in another study during the study period.
- •Individuals whom the investigator considers unsuitable for participation in this study.
研究组 & 干预措施
Others(Health Functional Food) : Participants will be randomly assigned to either Group A (test product followed by control product) or Group B (control product followed by test product). During each intervention period, participants will take one tablet of either the test product (containing a Perilla frutescens and peppermint extract complex) or the control product once a day with water for 4 weeks.
干预措施: Others(Health Functional Food) : Participants will be randomly assigned to either Group A (test product followed by control product) or Group B (control product followed by test product). During each intervention period, participants will take one tablet of either the test product (containing a Perilla frutescens and peppermint extract complex) or the control product once a day with water for 4 weeks.
研究者
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