Study to Investigate if Sucking a Coldamaris Lozenge Elutes Sufficient Iota-carrageenan to Inactivate Usual Common Cold Viruses

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

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-04

Study Completion Date

2020-11-10

Brief Summary

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Coldamaris lozenges are a medical device containing 10 mg carrageenan/lozenge. The goal of the study is to determine whether the iota-carrageenan content in the saliva of subjects who sucked Coldamaris® lozenges is sufficient to inhibit the replication of 4 of the most common respiratory viruses causing common cold. At least 29 subjects will be screened, in order to get 24 subjects included.

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Detailed Description

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Coldamaris lozenges are a medical device containing 10 mg carrageenan/lozenge. The goal of the study is to determine whether the iota-carrageenan content in the saliva of subjects who sucked Coldamaris® lozenges is sufficient to inhibit the replication of 4 of the most common respiratory viruses causing common cold. At least 29 subjects will be screened, in order to get 24 subjects included.

The primary objective is whether the mean iota-carrageenan concentration in saliva during sucking an iota-carrageenan containing lozenge reaches published IC90 values for HRV1a and HRV8.

The secondary objectives are whether the mean iota-carrageenan concentration in saliva (µg/ml; base line corrected) during sucking an iota-carrageenan containing lozenge reaches the respective IC90/MIC values (paired t-tests) of the clinical saliva samples for HRV1a, HRV8, hCoV OC43, influenza virus H1N1n and Coxsackie virus A10.

Conditions

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Common Cold Viral Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The saliva of subjects will be collected before and during sucking a Coldamaris lozenge.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carrageenan

Subjects sucking carageenan containing lozenge

Group Type EXPERIMENTAL

Coldamaris lozenges

Intervention Type DEVICE

sucking carageenan containing lozenge

Interventions

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Coldamaris lozenges

sucking carageenan containing lozenge

Intervention Type DEVICE

Other Intervention Names

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Betadine Quixx protect Quixx grip-protect

Eligibility Criteria

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Inclusion Criteria

* personally signed and dated informed consent
* healthy respiratory tract, no acute infection
* age \> 18 years

Exclusion Criteria

* subjects with signs of an acute respiratory infection
* subjects with a known hypersensitivity to one of the ingredients
* presence of pregnancy confirmed

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes