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

2014-08-27 03:18:35 | BioPortfolio

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.

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?

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Healthy

Intervention

Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)), film-coated sugar-pill

Location

Phillipps University, Clinic for Psychiatry and Psychotherapy
Marburg
Hesse
Germany
35039

Status

Completed

Source

Pascoe Pharmazeutische Praeparate GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:35-0400

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PubMed Articles [5634 Associated PubMed Articles listed on BioPortfolio]

Calcium and Magnesium Contents in Three Hypericum L. Species from Turkey.

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The safety of St John's wort (Hypericum perforatum) in pregnancy and lactation: A systematic review of rodent studies.

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Medical and Biotech [MESH] Definitions

Genus of perennial plants in the family CLUSIACEAE (sometimes classified as Hypericaceae). Herbal and homeopathic preparations are used for depression, neuralgias, and a variety of other conditions. Hypericum contains flavonoids; GLYCOSIDES; mucilage, TANNINS; volatile oils (OILS, ESSENTIAL), hypericin and hyperforin.

Use of a device (film badge) for measuring exposure of individuals to radiation. It is usually made of metal, plastic, or paper and loaded with one or more pieces of x-ray film.

A film base coated with an emulsion designed for use with x-rays.

The measurement of radiation by photography, as in x-ray film and film badge, by Geiger-Mueller tube, and by SCINTILLATION COUNTING.

Technique involving the passage of X-rays through oral structures to create a film record while a central tab or wing of dental X-ray film is being held between upper and lower teeth.

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