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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

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ClinicalTrials.gov Identifier: NCT01100645
Recruitment Status : Unknown
Verified April 2010 by Azidus Brasil.
Recruitment status was:  Not yet recruiting
First Posted : April 9, 2010
Last Update Posted : October 28, 2010
Sponsor:
Information provided by:
Azidus Brasil

Tracking Information
First Submitted Date  ICMJE April 7, 2010
First Posted Date  ICMJE April 9, 2010
Last Update Posted Date October 28, 2010
Study Start Date  ICMJE October 2010
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2010)
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;
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2010)
Improvement in sleep efficiency [ Time Frame: Before and after 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;
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2010)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2010)
Improvement of the values obtained by the answers of the questionnaires obtained during the treatment [ Time Frame: Before and after treatment ]
Scale Hamilton Anxiety (HAM-A); Daytime Sleepiness Scale Epworth; Journal of Sleep
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Not Provided
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE
  • Drug: Sominex
    Passiflora incarnata L.50 mg Valeriana officinalis L.40 mg Crataegus oxyacantha L.30 mg
  • Drug: Placebo
    Excipient
Study Arms  ICMJE
  • Experimental: Test
    Sominex ® (Passiflora incarnata L. 50 mg, Valeriana officinalis L. 40 mg and Crataegus oxyacantha L. 30 mg)
    Intervention: Drug: Sominex
  • Placebo Comparator: Placebo
    Excipient
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 8, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2011
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01100645
Other Study ID Numbers  ICMJE VCPEMS0210
Version 2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda.
Study Sponsor  ICMJE Azidus Brasil
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azidus Brasil
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP