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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

2014-07-23 21:09:35 | BioPortfolio

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

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.

Study Design

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

Conditions

Insomnia

Intervention

Sominex, Placebo

Location

LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos
São Paulo
Brazil

Status

Not yet recruiting

Source

L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:35-0400

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