Clinical trial to investigate the physiological effects on sleep of Nervenruh Baldrian Forte 600 in patients with restlessness and difficulty falling asleep due to nervousness

• Conditions: Primary (psychophysiologic) insomnia; MedDRA version: 13.1Level: LLTClassification code 10036701Term: Primary insomniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-000037-36-DE
• Lead Sponsor: MCM Klosterfrau GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-15
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified