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

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

Study Overview

• Status: Unknown
• Conditions: Insomnia
• Intervention / Treatment: Drug: Sominex; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Valinhos, São Paulo, Brazil
      • LAL Clínica Pesquisa e Desenvolvimento Ltda
      • Contact: Alexandre Frederico; Phone Number: +55 19 3871-6399; Email: alexandre@lalclinica.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Having participated in any experimental study or have ingested any drug trial within 12 months prior to the start of the study;
2. 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;
3. 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.;
4. Be patient with sensitivity to an association of herbal medicines;
5. Present history of alcohol abuse, drugs or medicines;
6. Pregnant or nursing women;
7. Owning a history of liver disease or renal impairment and / or thyroid dysfunction;
8. Patients with a history of restless sleep: nocturnal myoclonus or restless legs syndrome;
9. Patients with a history of snoring or bruxism exaggerated;
10. Diseases that affect sleep, causing pain or immobilization of the patient in bed;
11. Patients who have extensive work or working in night shifts totally or partially nocturnal;
12. 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;
13. Physical or psychological disorders that might interfere with the analysis of data such as neurosis, depression, muscle atrophy, and / or staying the medical criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Sominex ® (Passiflora incarnata L. 50 mg, Valeriana officinalis L. 40 mg and Crataegus oxyacantha L. 30 mg)	Drug: Sominex; Passiflora incarnata L.50 mg Valeriana officinalis L.40 mg Crataegus oxyacantha L.30 mg
Placebo Comparator: Placebo; Excipient	Drug: Placebo; Excipient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of the values obtained by the answers of the questionnaires obtained during the treatment	Scale Hamilton Anxiety (HAM-A); Daytime Sleepiness Scale Epworth; Journal of Sleep	28 days of treatment.

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): February 1, 2011

Study Registration Dates

• First Submitted: April 7, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Estimate): October 28, 2010
• Last Update Submitted That Met QC Criteria: October 26, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: VCPEMS0210; Version 2