Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep

Healthy Clinical Trial

— sleep-EEG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997256
• Other study ID #: PSC 152/04
• Status: Completed
• Phase: Phase 1
• First received: October 16, 2009
• Last updated: May 14, 2010
• Start date: December 2004
• Est. completion date: February 2005

Study information

• Verified date: May 2010
• Source: Pascoe Pharmazeutische Praeparate GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

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.

1. 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?

2. 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?

3. 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?

4. 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Study Design

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

Related Conditions & MeSH terms

• Healthy
• Sleep Quality

Intervention

Drug:
• Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))
3 x 2 tablets / day over 3 days
• film-coated sugar-pill
3 x 2 tablets / day over 3 days

Locations

Country	Name	City	State
Germany	Phillipps University, Clinic for Psychiatry and Psychotherapy	Marburg	Hesse

Sponsors (1)

Lead Sponsor	Collaborator
Pascoe Pharmazeutische Praeparate GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture)		Day 3 + 14	No
Secondary	Attention Stress Test d2 (Brickenkamp)		Day 4 + 15	No
Secondary	Alertness and vigilance test (TAP)		Day 4 + 15	No
Secondary	Trail-Making Test (TMT)		Day 4 + 15	No
Secondary	Questionnaire on physical symptoms of subjective well-Being(MKSL, Janke)		Day 4 +15	No
Secondary	Questionnaire on psychological aspects of well-being(BSKE, Janke)		Day 4 + 15	No
Secondary	ZERSSEN Scale of evaluation of subjective well-being (Bf-S)		Day 4 + 15	No
Secondary	Sleep Questionnaire(SF)		Day 4 + 15	No