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

NCT01100645 | Unknown Phase 3

• 2 other identifiers: VCPEMS0210Version 2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Improvement in sleep efficiency

  Quality of Sleep Questionnaire and the polysomnographic parameters: * Latency to onset of sleep; * Total time of sleep; * REM sleep latency; * Duration of REM sleep;

  28 days of treatment.

Secondary Outcomes (1)

• Improvement of the values obtained by the answers of the questionnaires obtained during the treatment

  28 days of treatment.

Study Arms (2)

Test

EXPERIMENTAL

Sominex ® (Passiflora incarnata L. 50 mg, Valeriana officinalis L. 40 mg and Crataegus oxyacantha L. 30 mg)

Drug: Sominex

Placebo

PLACEBO COMPARATOR

Excipient

Drug: Placebo

Interventions

Sominex DRUG

Passiflora incarnata L.50 mg Valeriana officinalis L.40 mg Crataegus oxyacantha L.30 mg

Test

Placebo DRUG

Excipient

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who agree and sign the informed consent form (ICF);
• Adult patients, aged ≥ 18 years and ≤ 65 years, male or female;
• Patients who agree to perform all study procedures;
• Patients diagnosed with psychophysiological insomnia;
• Patients who present in the application of sleep questionnaire result ≥ 25 and ≤ 30 points;
• Patients presenting in polysomnography change in any of the polysomnographic parameters than the normal range.

You may not qualify if:

• Having participated in any experimental study or have ingested any drug trial within 12 months prior to the start of the study;
• Be in use or have used other medications that interfere with the regular response of the drug at least 04 weeks prior to the start of the study, as benzodiazeínicos, antidepressants with sedative, sedatives, antihistamines and other herbal medicines;
• Being in treating or have been treated with alternative methods that interfere with the drug response to at least 04 weeks prior to the start of the study, such as behavioral therapies and relaxation techniques, such as yoga, massage, etc.;
• Be patient with sensitivity to an association of herbal medicines;
• Present history of alcohol abuse, drugs or medicines;
• Pregnant or nursing women;
• Owning a history of liver disease or renal impairment and / or thyroid dysfunction;
• Patients with a history of restless sleep: nocturnal myoclonus or restless legs syndrome;
• Patients with a history of snoring or bruxism exaggerated;
• Diseases that affect sleep, causing pain or immobilization of the patient in bed;
• Patients who have extensive work or working in night shifts totally or partially nocturnal;
• Patients in whom polysomnography demonstrating non-characteristic changes in sleep disturbances of psychophysiological origin as narcolepsy, hipopinéia syndrome, upper airway hypersensitivity syndrome of periodic limb movements, sleepwalking, among others;
• Physical or psychological disorders that might interfere with the analysis of data such as neurosis, depression, muscle atrophy, and / or staying the medical criteria.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

LAL Clinica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Diphenhydramine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 9, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 28, 2010

Record last verified: 2010-04

Locations

BR (1)