HealthyPhase 1sleep-EEGNCT00997256
Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep
A Phase 1 study testing Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)) and film-coated sugar-pill in people with Healthy and Sleep Quality, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
Trial summary
To demonstrate the influence of a herbal preparation containing hypericum, passionflower, and valerian on sleep structure, improvement of attention, and well-being in comparison to placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Sleep Quality
- What is being tested?
- Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)) and film-coated sugar-pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2004to Feb 2005
- Phase
- Phase 1
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged between 18 and 55 years
- Normal sleeping times (at least 6 hours a night), going to sleep between 22.00 and 1.00 hours, getting up between 6.00 and 9.00 hours
- Written informed consent
- The volunteer is willing and able to cooperate fully
- The volunteer agrees not to drink any alcohol for the duration of the study
Who cannot join
- Participation in another study in the last 30 days or participation in this study at an earlier date
- Lack of verbal or intellectual ability to communicate adequately and to understand the information to volunteers
- Legal incompetence
- Smoker
- Shift worker
- Transatlantic flight in the last 4 weeks
Show all 13Show fewer
- Taking psychotropic drugs within the last 4 weeks
- Taking medicines that influence the EEG within the last 4 weeks
- Diseases that influence the sleep EEG
- History of known medication / drug / alcohol misuse according to ICD-10 coding F10 - F19
- Known intolerance/hypersensitivity/allergy to St. John's wort, valerian or passionflower
- Taking inadmissible concomitant medication (anxiolytic, neuroleptic or hypnotic drugs, cyclosporin, sedative, sleep-promoting or mood-enhancing medicines, antidepressants other than the trial medication, coumarin-type anticoagulants, oral contraceptives, tranquillisers, homeopathic remedies, digoxin, theophylline, indinavir, nortriptyline, amitriptyline)
- Known light-sensitivity
Trial locations and contacts
1 site in 1 country.
Germany1 site
Phillipps University, Clinic for Psychiatry and Psychotherapy
Marburg, Hesse, 35039
About this study
Official title: Phase I, Placebo-controlled, Double-blind, Randomised, Single-centre Study of Single Cross-over Design to Investigate the Effects of the Herbal Preparation Neurapas® Balance Compared With Placebo on Sleep EEG, Mental Performance and Well-being
To demonstrate the influence of a herbal preparation containing hypericum, passionflower, and valerian on sleep structure, improvement of attention, and well-being in comparison to placebo.
Read the detailed description
To demonstrate the influence of the herbal combination preparation Neurapas® balance on the objective sleep structure in comparison with placebo. A further aim was to investigate whether treatment with Neurapas® balance versus placebo brings about an improvement in attention and well-being and whether these changes are related to the improvement in the sleep structure.
- Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in continuity of sleep?
- Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in sleep architecture, especially an increase in deep sleep?
- Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning attentional performance?
- Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning well-being?
- Conditions
- Healthy, Sleep Quality
- Being tested
- Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)), film-coated sugar-pill
- Keywords
- sleep-EEG, sleep architecture, sleep duration, sleep continuity, REM-sleep, vigilance, well-being, Healthy volunteers
- 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.
Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))Drug
Also called Neurapas balance, film-coated tablet over 3 days
3 x 2 tablets / day over 3 days
film-coated sugar-pillDrug
3 x 2 tablets / day over 3 days
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Neurapas balance, film-coated tablets Receives: Drug: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)) |
| Placebo | Placebo comparator | Film-coated sugar-pill Receives: Drug: film-coated sugar-pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture)
Measured: Day 3 + 14
Secondary outcomes (7)
Attention Stress Test d2 (Brickenkamp)
Measured: Day 4 + 15
Alertness and vigilance test (TAP)
Measured: Day 4 + 15
Trail-Making Test (TMT)
Measured: Day 4 + 15
Questionnaire on physical symptoms of subjective well-Being(MKSL, Janke)
Measured: Day 4 +15
Questionnaire on psychological aspects of well-being(BSKE, Janke)
Measured: Day 4 + 15
ZERSSEN Scale of evaluation of subjective well-being (Bf-S)
Measured: Day 4 + 15
Sleep Questionnaire(SF)
Measured: Day 4 + 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startDec 2004
- Primary completionJan 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ulrich M Hemmeter, PD Dr Dr, Principal investigator, Phillipps University Marburg, Clinic for Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997256
- Sponsor's protocol ID
- PSC 152/04
- Acronym
- sleep-EEG
- Status last verified
- May 2010
- First submitted
- 16 Oct 2009
- Last updated
- 17 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Placebo-controlled, Double-blind, Randomised, Single-centre Study of Single Cross-over Design to Investigate the Effects of the Herbal Preparation Neurapas® Balance Compared With Placebo on Sleep EEG, Mental Performance and Well-being
- ClinicalTrials.gov ID
- NCT00997256
- Acronym / sponsor ID
- sleep-EEG / PSC 152/04
- Conditions
- Healthy, Sleep Quality
- Keywords
- sleep-EEG, sleep architecture, sleep duration, sleep continuity, REM-sleep, vigilance, well-being, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 19 Oct 2009 (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.
To demonstrate the influence of a herbal preparation containing hypericum, passionflower, and valerian on sleep structure, improvement of attention, and well-being in comparison to placebo.
Detailed description
To demonstrate the influence of the herbal combination preparation Neurapas® balance on the objective sleep structure in comparison with placebo. A further aim was to investigate whether treatment with Neurapas® balance versus placebo brings about an improvement in attention and well-being and whether these changes are related to the improvement in the sleep structure.
- Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in continuity of sleep?
- Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in sleep architecture, especially an increase in deep sleep?
- Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning attentional performance?
- Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning well-being?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Drug: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))Neurapas balance, film-coated tablets |
| Placebo | Placebo comparator | Drug: film-coated sugar-pillFilm-coated sugar-pill |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male volunteers aged between 18 and 55 years
- Normal sleeping times (at least 6 hours a night), going to sleep between 22.00 and 1.00 hours, getting up between 6.00 and 9.00 hours
- Written informed consent
- The volunteer is willing and able to cooperate fully
- The volunteer agrees not to drink any alcohol for the duration of the study
Key exclusion criteria (13 listed)
- Participation in another study in the last 30 days or participation in this study at an earlier date
- Lack of verbal or intellectual ability to communicate adequately and to understand the information to volunteers
- Legal incompetence
- Smoker
- Shift worker
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 |
|---|---|---|
| Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))Also: Neurapas balance, film-coated tablet over 3 days3 x 2 tablets / day over 3 days | Drug | Verum |
| film-coated sugar-pill3 x 2 tablets / day over 3 days | Drug | Placebo |
Primary outcome
Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture)
Time frame: Day 3 + 14
7 secondary outcomes
Attention Stress Test d2 (Brickenkamp)
Time frame: Day 4 + 15
Alertness and vigilance test (TAP)
Time frame: Day 4 + 15
Trail-Making Test (TMT)
Time frame: Day 4 + 15
Questionnaire on physical symptoms of subjective well-Being(MKSL, Janke)
Time frame: Day 4 +15
Questionnaire on psychological aspects of well-being(BSKE, Janke)
Time frame: Day 4 + 15
ZERSSEN Scale of evaluation of subjective well-being (Bf-S)
Time frame: Day 4 + 15
Sleep Questionnaire(SF)
Time frame: Day 4 + 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 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.
Ulrich M Hemmeter, PD Dr Dr principal investigator
Phillipps University Marburg, Clinic for Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)) and film-coated sugar-pill in people with Healthy and Sleep Quality, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
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 5 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: finished, as of the sponsor's last update on 17 May 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture) (time frame: Day 3 + 14). 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 17 May 2010.