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

ISRCTN ISRCTN86579667
DOI https://doi.org/10.1186/ISRCTN86579667
Secondary identifying numbers UM007.2
Submission date
26/03/2003
Registration date
26/03/2003
Last edited
07/10/2021
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 titleEfficacy of EPs 7630 in children with acute non-streptococcal tonsillopharyngitis
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAcute tonsillopharyngitis
Intervention78 Children were randomised to receive either:
1. Herbal remedy EPs 7630, 20 drops per hour during the first 1 - 2 days, followed by 20 drops three times daily
2. Placebo, 20 drops per hour during the first 1 - 2 days, followed by 20 drops three times daily

The duration of individual treatment lasted over a maximum of 6 days.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)EPs 7630
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2003
Completion date31/12/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants78
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 h, negative dip-and-react-test test for ß-hemolytic streptococcus and severity of symptoms ≥6 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 enrolment31/12/2003

Locations

Countries of recruitment

  • Germany

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 07/10/2021 Yes No

Editorial Notes

07/10/2021: Publication reference added.