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NCT00997256: sleep-EEG
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
Phase 1 trial testing Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)) in Healthy in 20 participants. Completed in 1 February 2005.
1 January 2005
Quick facts
| Lead sponsor | Pascoe Pharmazeutische Praeparate GmbH |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 December 2004 |
| Primary completion | 1 January 2005 |
| Estimated completion | 1 February 2005 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)) — full drug profile →
- film-coated sugar-pill — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
- Sleep Quality — all drugs for Sleep Quality →
Sponsor
Pascoe Pharmazeutische Praeparate GmbH — full company profile →
Who can join
Adults 18 to 55, male only, with Healthy or Sleep Quality. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Evaluation of sleep by Polysomnography (sleep continuity and sleep architecture)
Time frame: Day 3 + 14
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00997256
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Pascoe Pharmazeutische Praeparate GmbH trials
Trials by the same sponsor.
- NCT05561257 — Vitamin C as add-on Therapy in Patients With Acute Herpes Zoster · Phase 2 · terminated
- NCT06983847 — A Long-term Observational Study to Describe the Use of Vitamin-C Injektopas® 7.5 g in Patients With Vitamin C Deficiency · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00997256 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pascoe Pharmazeutische Praeparate GmbH
- Last refreshed: 14 May 2010
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00997256.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing