Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep (sleep-EEG)

Pascoe Natural Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy; Sleep Quality

Treatments: Drug: film-coated sugar-pill; Drug: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))

Study type: Interventional

Funder types: Industry

Identifiers

NCT00997256

PSC 152/04

Details and patient eligibility

About

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.

Full 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?

Enrollment: 20 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Verum

Experimental group

Description:

Neurapas balance, film-coated tablets

Treatment:

Drug: Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian))

Placebo

Placebo Comparator group

Description:

Film-coated sugar-pill

Treatment:

Drug: film-coated sugar-pill