Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.

NCT ID: NCT03943186

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-13

Study Completion Date

2019-05-13

Brief Summary

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The goal of this non-interventional study is to investigate the safety, efficacy and tolerability of Ectoin Lozenges Honey Lemon (EHT02) compared to lozenges containing hyaluronic acid and islandic moss in the treatment of acute viral pharyngitis.

Detailed Description

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The current non-interventional study aims to investigate the efficacy and tolerability of Ectoin Lozenges Honey Lemon in patients suffering from acute viral pharyngitis. Participants receive treatments as part of routine medical care, and participants can choose one of two treatment options: a) Ectoin Lozenges Honey Lemon or b) lozenges containing hyaluronic acid and icelandic moss.

Efficacy will be studied by documentation of the following symptoms:

* pain on swallowing
* hoarseness
* urge to cough
* dry mouth and throat
* redness of oropharynx and larynx
* sore throat
* impairment of free breathing
* general feeling of illness

In parallel, participating patients will document their symptoms over the entire study duration in patient diaries.

The observation takes place over a period of seven days.

Conditions

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Acute Viral Pharyngitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Ectoin Lozenges Honey Lemon

application of 1 Lozenge every three hours or as often as required, not more than 10 lozenges per day

Ectoin Lozenges Honey Lemon

Intervention Type DEVICE

application of Ectoin Lozenges (EHT02) in accordance with the instructions for use

Hyaluronic acid/Icelandic moss Lozenges

application as often as required, not more than 6 lozenges per day

Hyaluronic Acid/Icelandic moss Lozenges

Intervention Type DEVICE

application of the lozenges in accordance with the instructions for use

Interventions

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Ectoin Lozenges Honey Lemon

application of Ectoin Lozenges (EHT02) in accordance with the instructions for use

Intervention Type DEVICE

Hyaluronic Acid/Icelandic moss Lozenges

application of the lozenges in accordance with the instructions for use

Intervention Type DEVICE

Other Intervention Names

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EHT02

Eligibility Criteria

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Inclusion Criteria

* patients with acute viral pharyngitis

Exclusion Criteria

* patients with known intolerance to one of the substances used
* Pregnancy
* Surgical Procedures in the mouth and throat region prior to the study
* Bacterial Pharyngitis
* symptoms in the throat since more than 5 days
* Contraindications according to the instructions for use
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitop AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Bilstein, Dr

Role: STUDY_DIRECTOR

CSO

Locations

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bitop AG

Dortmund, , Germany

Site Status

Countries

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Germany

Other Identifiers

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btph-014-2018-EHT02

Identifier Type: -

Identifier Source: org_study_id

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