Efficacy of EPs 7630 compared to placebo in children with acute non-streptococcal tonsillopharyngitis

ISRCTN ISRCTN27398531
DOI https://doi.org/10.1186/ISRCTN27398531
Secondary identifying numbers UM012
Submission date
26/03/2003
Registration date
26/03/2003
Last edited
15/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marianne Heger
Scientific

Director Research Center HomInt
PO Box 41 02 40
Karlsruhe
76202
Germany

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAcute tonsillopharyngitis
Intervention124 Children were randomised to receive either:
1. Herbal remedy EPs 7630, 20 drops three times daily
2. Placebo, 20 drops three times daily.

The duration of individual treatment lasted over a maximum of 6 days.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2003
Completion date01/06/2003

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Years
Upper age limit10 Years
SexBoth
Target number of participants124
Key inclusion criteriaPatients who met the following inclusion criteria were suitable for the trial:
1. Age 6 - 10 years, acute tonsillopharyngitis, duration of complaints less than 48 hours, negative dip-and-react-test test for beta-hemolytic streptococcus and severity of symptoms greater than or equal to 8 points
2. In addition legal guardians had to sign an informed consent
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2003
Date of final enrolment01/06/2003

Locations

Countries of recruitment

  • Germany
  • Ukraine

Study participating centre

Director Research Center HomInt
Karlsruhe
76202
Germany

Sponsor information

ISO Arzneimittel GmbH & Co KG (Germany)
Industry

Bunsenstrasse 6-10
Ettlingen
76275
Germany

Website http://www.iso-arznei.de
ROR logo "ROR" https://ror.org/045xrc244

Funders

Funder type

Industry

ISO Arzneimittel GmbH & Co KG (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/09/2003 Yes No