Open label clinical trial to investigate the physiological effects on sleep of Nervenruh Baldrian Forte 600 in patients with primary insomnia

MCM Klosterfrau GmbH & Co. KG0 个研究点开始时间: 2011年3月15日最近更新: 2012年4月18日

适应症

试验速览

暂无简介。

•- Male and female patients, aged 18-60 years
•- Written informed consent of the patients
•- Sleep onset latency value between 15 min and 45 min (Polysomnographic evaluation)
•- Total sleep time value between 3 h and 7 h (Polysomnographic evaluation)
•- Current diagnosis of primary insomnia using ICSD-2 criteria
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Secondary insomnia criteria
•- Serious diseases which preclude a patient’s participation in the investigator’s opinion
•- Pregnancy or breast-feeding. Premenopausal women must use an approved birth control method.
•- Any current diagnosis of alcohol or substance abuse/dependence (with the exception of cigarette smoking)
•- Regular (= 4 times per week for at least 4 weeks) intake of sedatives / hypnotics / antihistamines, sedating antidepressants and beta-blockers (abstinence time: 7 days prior to PSG screening night)
•- Known sensitivity to the ingredients of the IMP
•- Simultaneous participation in another clinical trial or participation in a clinical trial during 6 weeks before start of this clinical trial

发起方

MCM Klosterfrau GmbH & Co. KG