InsomniaPhase 3NCT01100645
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
A Phase 3 study testing Sominex in people with Insomnia, run by Azidus Brasil at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Sominex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2010to Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo
Alexandre Frederico, +55 19 3871-6399, alexandre@lalclinica.com.br
About this study
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
Read the 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.
- Conditions
- Insomnia
- Being tested
- Sominex, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SominexDrug
Passiflora incarnata L.50 mg Valeriana officinalis L.40 mg Crataegus oxyacantha L.30 mg
PlaceboDrug
Excipient
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Sominex ® (Passiflora incarnata L. 50 mg, Valeriana officinalis L. 40 mg and Crataegus oxyacantha L. 30 mg) Receives: Drug: Sominex |
| Placebo | Placebo comparator | Excipient Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 28 days of treatment.
Secondary outcomes (1)
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
Measured: 28 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100645
- Sponsor's protocol ID
- VCPEMS0210
- Other IDs
- Version 2
- Status last verified
- Apr 2010
- First submitted
- 7 Apr 2010
- Last updated
- 28 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01100645
- Acronym / sponsor ID
- VCPEMS0210
- Conditions
- Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: SominexSominex ® (Passiflora incarnata L. 50 mg, Valeriana officinalis L. 40 mg and Crataegus oxyacantha L. 30 mg) |
| Placebo | Placebo comparator | Drug: PlaceboExcipient |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SominexPassiflora incarnata L.50 mg Valeriana officinalis L.40 mg Crataegus oxyacantha L.30 mg | Drug | Test |
| PlaceboExcipient | Drug | Placebo |
Primary outcome
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;
1 secondary outcome
Improvement of the values obtained by the answers of the questionnaires obtained during the treatment
Time frame: 28 days of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sominex in people with Insomnia, run by Azidus Brasil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in sleep efficiency (time frame: 28 days of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2010.