ISRCTN12126820进行中（未招募）Unknown
Efficacy study of a food supplement based on Scutellaria lateriflora L. (aerial parts of the plant) for sleep management: single-center, controlled, randomized, cross-over, double-bind clinical study with a run-in period.
Epo S.r.l.0 个研究点目标入组 66 人开始时间: 2024年6月3日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
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
- 性别
- All
入选标准
- •1.Subjects aged 18 - 70 years of both sexes
- •2.Subjects able to understand and sign the informed consent
- •3.With primary insomnia, present for at least one month
- •4.With ISI questionnaire scores <22
- •5.With GAD-7 questionnaire scores <5
- •6.With PHQ-9 questionnaire scores <5
排除标准
- •1.Aged < 18 and > 70 years
- •2.Pregnant or breastfeeding individuals
- •3.Subjects with secondary insomnia or other sleep disorders, such as obstructive sleep apnea, narcolepsy, nocturnal myoclonus, restless legs syndrome, advanced sleep phase disorder, delayed sleep phase disorder, paradoxical insomnia, parasomnias
- •4.Subjects with ISI questionnaire scores >22
- •5.Subjects with GAD-7 questionnaire scores >5
- •6.Subjects with PHQ-9 questionnaire scores >5
- •7.Subjects suffering from psychiatric disorders: major depression, generalized anxiety disorder, post-traumatic stress disorder, panic attacks, bipolar disorder, dementia, schizophrenia
- •8.Subjects with chronic and acute pain conditions (e.g., arthritis, fibromyalgia, back pain, headaches, respiratory diseases, asthma, diabetes, heart diseases, injuries, hyperthyroidism, gastroesophageal reflux, epilepsy, Parkinson's disease, Alzheimer's disease, kidney diseases)
- •9.Subjects who abuse alcohol, amphetamines, caffeine, theine
- •10.Subjects taking antidepressants, diuretics
- •11.Subjects with hypothyroidism
- •12.Subjects who have taken monoamine oxidase inhibitors in the 14 days prior to recruitment
- •13.Subjects taking antibiotics or who have taken antibiotics in the last four weeks, or in the last 6 months, based on the intensity and duration of antibiotic treatment
- •14.Subjects with cognitive disorders that may hinder the response to questionnaires
- •15.Subjects with known allergy to the ingredients of the experimental products (active - placebo)
- •16.Subjects with acquired immunodeficiency syndrome from HIV
研究者
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