EUCTR2015-003265-29-DE进行中（未招募）1 期
Proof of concept trial to evaluate the effectiveness of combined treatment with Valerian extract (Euvegal®) and Lavender oil (Lasea®) in patients suffering from inability to fall or stay asleep
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
入选标准
- •1. Patients not able to fall or stay asleep with a diagnosis of non organic insomnia according to ICD 10 F 51.0 and according to PSG screening criteria: 2-night mean latency to persisting sleep (LPS) > 30 min, Wake-time during sleep (WTDS) > 30 min and Total sleep time (TST) > 180 min and < 390 min.
- •2. No organic reason for sleep disturbances.
- •3. Insomnia Severity Index (ISI) score >= 15 at screening.
- •4. Patients otherwise healthy / medically stable on the basis of clinical laboratory tests, medical history, vital signs, and 12-lead ECG performed at screening.
- •5. Patients aged between 18 and 50 years (at the time of informed consent).
- •6. Body mass index (BMI) between 18 and 30 kg/m2 inclusive
- •7. Written informed consent to participate in the clinical trial, to randomised treatment allocation and to data recording in accordance with applicable laws.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Participation in another clinical trial at the same time or exposure to any new investigational agent within 90 days prior to study drug administration.
- •2. Women of postmenopausal state (>45 years of age with amenorrhea for at least 12 months).
- •3. Using nicotine-containing products moderately (= 10 cigarettes/day), or within 120 minutes of bedtime during the clinical trial.
- •4. Consuming > 5 caffeine-containing beverages (tea/coffee/cocoa/cola) /day within the last two months .
- •5. Patients who do not agree to abstain from caffeine-containing products 6 hours before dosing of investigational medicinal product (IMP).
- •6. Presence or history of clinically relevant allergies or a known or suspected intolerance or hypersensitivity to one of the IMP, closely related compounds, any of the stated ingredients or to excipients contained in the tablets/capsules.
- •7. Female patients, who are pregnant, breast-feeding or of childbearing potential without safe contraception.
- •8. Any clinically relevant concomitant disease, gastrointestinal disorders with uncertain absorption of orally administered drugs, severe renal dysfunction; hepatic impairment (serum ASAT, ALAT or gamma-GT above 2 times the upper limit of the reference range in symptom-free patients without clinical features of liver disease); hypothyroidism or hyperthyroidism; significant cardiac, vascular, pulmonary, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbances.
- •9. Current diagnosis of a psychotic disorder, major depressive disorder, bipolar disorder, mental retardation, or cluster B personality disorder.
- •10. Clinically significant acute illness within seven days prior to first study drug administration.
- •11. Insomnia related to restless leg syndrome on first or second night PSG recording, sleep breathing disorder on first or second night PSG recording, narcolepsy, obstructive sleep apnea/hypopnea, central sleep apnea, sleep-related hypoventilation, circadian rhythm sleep-wake disorders, substance/medication-induced sleep disorder or parasomnias.
- •12. Night-shift workers.
- •13. Patients who have traveled across 3 different time zones within 1 week prior to screening PSG.
- •14. Patients who are HIV positive or hepatitis B positive.
- •15. History of substance or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) criteria within 6 months before screening or positive test result(s) for alcohol and/or drugs of abuse at screening or admission before every PSG night.
- •16. Donation of one or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 90 days prior to study drug administration.
- •17. Intake of drugs not permitted during the trial.
- •18. Patients not able to swallow.
- •19. Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements.
- •20. Is unable to read and understand the consent forms and patient reported outcomes, complete study-related procedures, and/or communicate with the study staff.
- •21. Vulnerable subjects (e.g., a person kept in detention).
研究者
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