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 because the information has not been verified recently.
Verified April 2010 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01100645
First received: April 7, 2010
Last updated: October 26, 2010
Last verified: April 2010
  Purpose

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

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Improvement in sleep efficiency [ Time Frame: 28 days of treatment. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]
    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
Excipient
Drug: Placebo
Excipient

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100645

Locations
Brazil
LAL Clinica Pesquisa e Desenvolvimento Ltda Not yet recruiting
Valinhos, São Paulo, Brazil
Contact: Alexandre Frederico    +55 19 3871-6399    alexandre@lalclinica.com.br   
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

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

ClinicalTrials.gov processed this record on September 18, 2014