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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carrageenan | Experimental | Subjects sucking carageenan containing lozenge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coldamaris lozenges | Device | sucking carageenan containing lozenge |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is the iota-carrageenan concentration in saliva. | The mean iota-carrageenan concentration in saliva during sucking an iota-carrageenan containing lozenge should reach published IC90 values for 2 human rhinoviruses. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome measure is the iota-carrageenan concetration in salvia. | Iota-carrageenan concentration in saliva of subjects should be high enough to inhibit replication of human rhinoviruses, human Coronavirus OC43, human influenzavirus H1N1n, and Coxsackievirus A10. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Friedrich Ehrenreich | Vienna | 1170 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34526804 | Derived | Morokutti-Kurz M, Unger-Manhart N, Graf P, Rauch P, Kodnar J, Grosse M, Setz C, Savli M, Ehrenreich F, Grassauer A, Prieschl-Grassauer E, Schubert U. The Saliva of Probands Sucking an Iota-Carrageenan Containing Lozenge Inhibits Viral Binding and Replication of the Most Predominant Common Cold Viruses and SARS-CoV-2. Int J Gen Med. 2021 Sep 7;14:5241-5249. doi: 10.2147/IJGM.S325861. eCollection 2021. |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003384 | Coxsackievirus Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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The saliva of subjects will be collected before and during sucking a Coldamaris lozenge.
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| D012140 |
| Respiratory Tract Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D004769 | Enterovirus Infections |