NCT01100645

Efficacy and Safety of the Herbal Medicine Sominex ® (Passiflora Incarnata L., Valeriana Officinalis L. and Crataegus Oxyacantha L.), Manufactured by the Laboratory EMS S / A in Patients With Psychophysiological Insomnia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to evaluate the clinical efficacy of the drug Sominex (Valeriana officinalis L., 40 mg, 30 mg Crataegus oxyacantha L. and Passiflora incarnata L. 50 mg) manufactured by the Laboratory EMS S / A, compared to placebo in improving sleep efficiency, based on the response of the sleep quality questionnaire (MSQ) and polysomnographic parameters described below: * Latency to onset of sleep; * Total time of sleep; * Rapid eye movement (REM) sleep latency; * Duration of REM sleep

Detailed description

Verify the effectiveness of the drug Sominex compared to placebo based on the improvement of the following parameters measured by the following validated scales: * Anxiety; * Daytime sleepiness; Will also be assessed secondary to drug safety testing for the occurrence, type, frequency and intensity of adverse events during treatment.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Sominex	Passiflora incarnata L.50 mg Valeriana officinalis L.40 mg Crataegus oxyacantha L.30 mg
DRUG	Placebo	Excipient

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-01-01
• Completion: 2011-02-01
• First posted: 2010-04-09
• Last updated: 2010-10-28

Locations

1 site across 1 country: Brazil