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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Azidus Brasil.
Recruitment status was:  Not yet recruiting
Information provided by:
Azidus Brasil Identifier:
First received: April 7, 2010
Last updated: October 26, 2010
Last verified: April 2010

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

Condition Intervention Phase
Insomnia Drug: Sominex Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • Improvement in sleep efficiency [ Time Frame: 28 days of treatment. ]

    Quality of Sleep Questionnaire and the polysomnographic parameters:

    • Latency to onset of sleep;
    • Total time of sleep;
    • REM sleep latency;
    • Duration of REM sleep;

Secondary Outcome Measures:
  • Improvement of the values obtained by the answers of the questionnaires obtained during the treatment [ Time Frame: 28 days of treatment. ]
    Scale Hamilton Anxiety (HAM-A); Daytime Sleepiness Scale Epworth; Journal of Sleep

Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01100645

LAL Clinica Pesquisa e Desenvolvimento Ltda Not yet recruiting
Valinhos, São Paulo, Brazil
Contact: Alexandre Frederico    +55 19 3871-6399   
Sponsors and Collaborators
Azidus Brasil
  More Information

Responsible Party: Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda. Identifier: NCT01100645     History of Changes
Other Study ID Numbers: VCPEMS0210
Version 2
Study First Received: April 7, 2010
Last Updated: October 26, 2010

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anti-Allergic Agents
Dermatologic Agents processed this record on September 21, 2017