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 status
• Trial end date: 2011-02-01

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

• Phase: Phase 3

Details

• Lead Sponsor: Azidus Brasil
• Treatments: Diphenhydramine; Promethazine