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Clinical Trial (according to §23b MPG) on performance, safety and clinical benefit of hysan Pflegespray, hysan Hyaluronspray and Ocean-Spray Plus in otorhinolaryngology.

Clinical Trial (according to §23b MPG) on performance, safety and clinical benefit of hysan Pflegespray, hysan Hyaluronspray and Ocean-Spray Plus in otorhinolaryngology. - RISICCA-2017

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00013357
Enrollment
201
Registered
2017-11-22
Start date
2017-12-04
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dry nose

Interventions

Group 1: hysan Pflegespray, nasal spray. Apply 1-2 sprays into each nostril several times a day, as needed. Group 2: hysan Hyaluronspray, nasal spray. Apply 1-2 sprays into each nostril several times

Sponsors

URSAPHARM Arzneimittel GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0 Years to 110 Years

Inclusion criteria

Inclusion criteria: - Use of the nasal sprays in adults and children within the intended use - indication for Treatment of dry nose symptoms - at least three of the clinical symptoms have a value of "mild", "moderate", "strong" or "very strong" or at least two symptoms have a value of "strong" or "very strong" - decision of the physician to recommend the use of a nasal spray has been made before the inclusion of the Patient in the Trial - patients are enrolled only after they had been given sufficient Information and had provided written consent

Exclusion criteria

Exclusion criteria: patients that do not fulfill the inclusion criteria

Design outcomes

Primary

MeasureTime frame
Evaluation of clinical symptoms by the patients, Rhinitis Sicca Symptom Score.

Secondary

MeasureTime frame
•Evaluation of the nasal spray •Duration of symptom improvement •Endoscopic Evaluation by the physicians •Global evalution by Patient and physician

Countries

Germany

Contacts

Public ContactPeter Meiser

URSAPHARM Arzneimittel GmbH

info@ursapharm.de06805-9292-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 19, 2026