Effectiveness of Local Application of Warm Air in Patients With Common Cold (HELI Study)

NCT ID: NCT00552981

Last Updated: 2012-07-10

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

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-04-30

Brief Summary

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In a randomized controlled trial, the investigators include patients with beginning symptoms of a common cold and compare two interventions:

1. the inhalation of warm air for inducing a warming of the throat and
2. the inhalation of ambient air as control. As outcome the effect on symptoms and duration of the common cold will be assessed. The interventions will consist of visits with a duration of 2-3 minutes on three following days in a Finnish sauna. Patients will be fully dressed.

Detailed Description

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Conditions

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Common Cold

Keywords

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common cold Finnish sauna rct

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

inhalation of warm air in a Finnish sauna

Intervention Type PROCEDURE

three times on three following days, each 2-3 minutes

2

Group Type SHAM_COMPARATOR

inhalation of ambient air in a Finnish sauna

Intervention Type PROCEDURE

three times on three following days, each 2-3 minutes

Interventions

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inhalation of warm air in a Finnish sauna

three times on three following days, each 2-3 minutes

Intervention Type PROCEDURE

inhalation of ambient air in a Finnish sauna

three times on three following days, each 2-3 minutes

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* symptom duration between 2 and 24 hours
* at least two of the ten following symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, sore throat, sneezing, and fever
* no usage of medication bought in a pharmacy
* informed consent

Exclusion Criteria

* fever \>38.5°C
* systolic blood pressure below 100 mmHg or above 160 mmHg
* severe chronic disease, which makes study participation impossible
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karl and Veronica Carstens Foundation

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia M. Witt

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia M. Witt, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany

Locations

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Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center

Berlin, , Germany

Site Status

Countries

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Germany

References

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Pach D, Knochel B, Ludtke R, Wruck K, Willich SN, Witt CM. Visiting a sauna: does inhaling hot dry air reduce common cold symptoms? A randomised controlled trial. Med J Aust. 2010 Dec 6-20;193(11-12):730-4. doi: 10.5694/j.1326-5377.2010.tb04127.x.

Reference Type RESULT
PMID: 21143077 (View on PubMed)

Other Identifiers

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HELI-2007

Identifier Type: -

Identifier Source: org_study_id