NCT00997256

Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep

Phase I, Placebo-controlled, Double-blind, Randomised, Single-centre Study of Single Cross-over Design to Investigate the Effects of the Herbal Preparation Neurapas® Balance Compared With Placebo on Sleep EEG, Mental Performance and Well-being

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pascoe Pharmazeutische Praeparate GmbH · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To demonstrate the influence of a herbal preparation containing hypericum, passionflower, and valerian on sleep structure, improvement of attention, and well-being in comparison to placebo.

Detailed description

To demonstrate the influence of the herbal combination preparation Neurapas® balance on the objective sleep structure in comparison with placebo. A further aim was to investigate whether treatment with Neurapas® balance versus placebo brings about an improvement in attention and well-being and whether these changes are related to the improvement in the sleep structure. 1. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in continuity of sleep? 2. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in sleep architecture, especially an increase in deep sleep? 3. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning attentional performance? 4. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning well-being?

Conditions

• Healthy
• Sleep Quality

Interventions

Type	Name	Description
DRUG	Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))	3 x 2 tablets / day over 3 days
DRUG	film-coated sugar-pill	3 x 2 tablets / day over 3 days

Timeline

• Start date: 2004-12-01
• Primary completion: 2005-01-01
• Completion: 2005-02-01
• First posted: 2009-10-19
• Last updated: 2010-05-17

Locations

1 site across 1 country: Germany