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
Primary Purpose
Insomnia
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Sominex
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
Inclusion Criteria:
- Patients who agree and sign the informed consent form (ICF);
- Adult patients, aged ≥ 18 years and ≤ 65 years, male or female;
- Patients who agree to perform all study procedures;
- Patients diagnosed with psychophysiological insomnia;
- Patients who present in the application of sleep questionnaire result ≥ 25 and ≤ 30 points;
- Patients presenting in polysomnography change in any of the polysomnographic parameters than the normal range.
Exclusion Criteria:
- Having participated in any experimental study or have ingested any drug trial within 12 months prior to the start of the study;
- 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;
- 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.;
- Be patient with sensitivity to an association of herbal medicines;
- Present history of alcohol abuse, drugs or medicines;
- Pregnant or nursing women;
- Owning a history of liver disease or renal impairment and / or thyroid dysfunction;
- Patients with a history of restless sleep: nocturnal myoclonus or restless legs syndrome;
- Patients with a history of snoring or bruxism exaggerated;
- Diseases that affect sleep, causing pain or immobilization of the patient in bed;
- Patients who have extensive work or working in night shifts totally or partially nocturnal;
- 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;
- Physical or psychological disorders that might interfere with the analysis of data such as neurosis, depression, muscle atrophy, and / or staying the medical criteria.
Sites / Locations
- LAL Clinica Pesquisa e Desenvolvimento Ltda
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test
Placebo
Arm Description
Sominex ® (Passiflora incarnata L. 50 mg, Valeriana officinalis L. 40 mg and Crataegus oxyacantha L. 30 mg)
Excipient
Outcomes
Primary Outcome Measures
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;
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01100645
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
February 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Azidus Brasil
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
Sominex ® (Passiflora incarnata L. 50 mg, Valeriana officinalis L. 40 mg and Crataegus oxyacantha L. 30 mg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Excipient
Intervention Type
Drug
Intervention Name(s)
Sominex
Intervention Description
Passiflora incarnata L.50 mg Valeriana officinalis L.40 mg Crataegus oxyacantha L.30 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Excipient
Primary Outcome Measure Information:
Title
Improvement in sleep efficiency
Description
Quality of Sleep Questionnaire and the polysomnographic parameters:
Latency to onset of sleep;
Total time of sleep;
REM sleep latency;
Duration of REM sleep;
Time Frame
28 days of treatment.
Secondary Outcome Measure Information:
Title
Improvement of the values obtained by the answers of the questionnaires obtained during the treatment
Description
Scale Hamilton Anxiety (HAM-A); Daytime Sleepiness Scale Epworth; Journal of Sleep
Time Frame
28 days of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who agree and sign the informed consent form (ICF);
Adult patients, aged ≥ 18 years and ≤ 65 years, male or female;
Patients who agree to perform all study procedures;
Patients diagnosed with psychophysiological insomnia;
Patients who present in the application of sleep questionnaire result ≥ 25 and ≤ 30 points;
Patients presenting in polysomnography change in any of the polysomnographic parameters than the normal range.
Exclusion Criteria:
Having participated in any experimental study or have ingested any drug trial within 12 months prior to the start of the study;
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;
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.;
Be patient with sensitivity to an association of herbal medicines;
Present history of alcohol abuse, drugs or medicines;
Pregnant or nursing women;
Owning a history of liver disease or renal impairment and / or thyroid dysfunction;
Patients with a history of restless sleep: nocturnal myoclonus or restless legs syndrome;
Patients with a history of snoring or bruxism exaggerated;
Diseases that affect sleep, causing pain or immobilization of the patient in bed;
Patients who have extensive work or working in night shifts totally or partially nocturnal;
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;
Physical or psychological disorders that might interfere with the analysis of data such as neurosis, depression, muscle atrophy, and / or staying the medical criteria.
Facility Information:
Facility Name
LAL Clinica Pesquisa e Desenvolvimento Ltda
City
Valinhos
State/Province
São Paulo
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Frederico
Phone
+55 19 3871-6399
Email
alexandre@lalclinica.com.br
12. IPD Sharing Statement
Learn more about this trial
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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