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ISRCTN
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ISRCTN03930168
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ClinicalTrials.gov identifier
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Public title
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Efficacy of EPs 7630 in acute non-streptococcal tonsillopharyngitis
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Scientific title
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Acronym
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N/A
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Serial number at source
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UM002
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Study hypothesis
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This study was a prospective, monocentre, randomised, open clinical pilot trial, comparing the efficacy of the herbal medicine EPs 7630 versus symptomatic therapy in patients with acute, non-streptococcal tonsillopharyngitis.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Acute, non-streptococcal tonsillopharyngitis
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Participants - inclusion criteria
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The study took place between March and April 1997. It is terminated. Patients, who met the following inclusion criteria, were suitable for the trial:
1. Age 6-10 years
2. Acute exsudative tonsillopharyngitis
3. Duration of symptoms less than 48 h
4. No Group A Beta Hemolytic Streptococcus (GABHS)-infection
5. Tonsillopharyngitis Severity Score (TSS) 6 or more points, and
6. Informed consent in writing by legal guardians who were able to understand the nature, meaning and consequences of the trial
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/03/1997
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Anticipated end date
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30/04/1997
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Status of trial
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Completed
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Patient information material
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Target number of participants
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60
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Interventions
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60 patients were randomised to receive either:
1. Herbal remedy EPs 7630, 20 drops thrice daily, or
2. Symptomatic therapy (gargling with fruit vinegar and lukewarm water, Priessnitz compresses).
The duration of individual treatment lasted over a maximum of 10 days.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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ISO Arzneimittel GmbH & Co KG
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Trial website
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Publications
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Contact name
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Dr
Marianne
Heger
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Address
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Director Research Center HomInt
PO Box 41 02 40
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City/town
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Karlsruhe
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Zip/Postcode
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76202
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Country
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Germany
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Sponsor
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ISO Arzneimittel GmbH & Co KG (Germany)
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Address
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Bunsenstrasse 6-10
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City/town
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Ettlingen
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Zip/Postcode
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76275
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Country
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Germany
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Sponsor website:
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http://www.iso-arznei.de
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Date applied
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14/06/2002
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Last edited
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02/10/2007
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Date ISRCTN assigned
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14/06/2002
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