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Clinical Trials/NCT00552981
NCT00552981
Completed
Not Applicable

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

Charite University, Berlin, Germany1 site in 1 country157 target enrollmentNovember 2007
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ConditionsCommon Cold

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Common Cold
Sponsor
Charite University, Berlin, Germany
Enrollment
157
Locations
1
Primary Endpoint
Symptom Score for Common Cold
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.
Registry
clinicaltrials.gov
Start Date
November 2007
End Date
April 2009
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claudia M. Witt

Prof. Dr. med.

Charite University, Berlin, Germany

Eligibility Criteria

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

Outcomes

Primary Outcomes

Symptom Score for Common Cold

Time Frame: Area under the curve day 2 to 7

Secondary Outcomes

  • generalized feeling ill on a numeric rating scale 0-10,(Day 1, 2, 3, 5 and 7)
  • safety (adverse events and serious adverse events)(1 to 7 days)
  • Usage of medication against common cold(Day 1 to 7)

Study Sites (1)

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