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
Information source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia
Intervention: Sominex (Drug); Placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Improvement in sleep efficiency
Secondary outcome: Improvement of the values obtained by the answers of the questionnaires obtained during the treatment
Verify the effectiveness of the drug Sominex compared to placebo based on the improvement of
the following parameters measured by the following validated scales:
- Daytime sleepiness; Will also be assessed secondary to drug safety testing for the
occurrence, type, frequency and intensity of adverse events during treatment.
Minimum age: 18 Years.
Maximum age: 65 Years.
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
6. Patients presenting in polysomnography change in any of the polysomnographic
parameters than the normal range.
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
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
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
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.
Locations and Contacts
LAL Clinica Pesquisa e Desenvolvimento Ltda, Valinhos, São Paulo, Brazil; Not yet recruiting
Alexandre Frederico, Phone: +55 19 3871-6399, Email: email@example.com
Starting date: October 2010
Last updated: October 26, 2010