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

Insomnia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01100645
• Other study ID #: VCPEMS0210
• Secondary ID: Version 2
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 7, 2010
• Last updated: October 26, 2010
• Start date: October 2010
• Est. completion date: February 2011

Study information

• Verified date: April 2010
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• Sominex
Passiflora incarnata L.50 mg Valeriana officinalis L.40 mg Crataegus oxyacantha L.30 mg
• Placebo
Excipient

Locations

Country	Name	City	State
Brazil	LAL Clinica Pesquisa e Desenvolvimento Ltda	Valinhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No