CTIS2023-508169-34-00进行中（未招募）1 期
Efficacy and safety of Escholzia tablets in adults with insomnia: a biphasic study with a randomized, placebo-controlled, double-blind, 1-month interventional, clinical trial phase (A) and a subsequent prospective, 1-armed, 2-months interventional trial phase (B). - Vo02-2023
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- A.Vogel AG
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Voluntary, written, informed consent to participate in the study., Male or female aged between 18-65 years (inclusive)., Diagnosis of insomnia according to ICD-10 F51.0., ISI total score > 7., Habitual bedtime between 9 pm and midnight., Easy access to internet for daily e-diary., Freezing capacities available for storage of saliva samples.
排除标准
- •Body mass index (BMI) <18.0 or >30.0 kg/m2., Have learning and/or behavioral difficulties such as dyslexia or attention deficit hyperactivity disorder (ADHD)., Have a visual impairment that cannot be corrected with glasses or contact lenses (including color-blindness)., History or planned travel to a different time zone within 1 month of the first visit or/and during the study participation., Shift-workers., Not fluent in German., Have (known) hypersensitivity to plants from the poppy family (Papaveraceae) or known hypersensitivity to the active substance/s (Eschscholzia californica, microcrystalline cellulose, Colloidal anhydrous silica, sodium croscarmellose, glycerol distearate, caramel couleur and Ferrous(III) oxide )., Participation in another study with any investigational product within 30 days of screening and during the intervention period., Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study., Individual is pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period., Any known acute history of a disorder affecting sleep quality, such as narcolepsy, obstructive sleep apnea (OSA), restless leg syndrome (RLS), periodic limb movement syndrome (PLMS) or any organic caused sleep disorders e.g. benign prostatic hyperplasia (BPH), urinary tract infections, irritated bladder, Any known acute history of psychiatric illness (e.g., mono- or bipolar depression, anxiety disorders, personality disorders, borderline personality disorder, psychoses)., Have a significant acute or chronic coexisting illness or any condition which contraindicates entry to the study in the opinion of the Investigator (e.g. migraines, active infections, renal insufficiency, hepatopathy, dementia)., Current or recent (within past 4 weeks) intake of drugs that could influence sleep (e.g., psychotropic, sedatives, hypnotics, nicotine-replacement therapies, over-the-counter sleep aids, hormone therapy, health products and oriental herbs (such as valerian, hops, passionflower, hypericum, etc.)., Current or recent (within 1 year) alcohol abuse, heavy smoking (>10 cigarettes/day), high caffeine intake (>10 glasses/day)., Self-declared regular illicit drug use (including cannabis and cocaine)., Have a high blood pressure (systolic over 159 mmHg or diastolic over 99 mmHg).
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