Condition category
Respiratory
Date applied
26/03/2003
Date assigned
26/03/2003
Last edited
07/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marianne Heger

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UM007.2

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Acute tonsillopharyngitis

Intervention

78 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 type

Drug

Phase

Not Specified

Drug names

EPs 7630

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

78

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2003

Recruitment end date

31/12/2003

Locations

Countries of recruitment

Germany

Trial participating centre

Director Research Center HomInt
Karlsruhe
76202
Germany

Sponsor information

Organisation

ISO Arzneimittel GmbH & Co KG (Germany)

Sponsor details

Bunsenstrasse 6-10
Ettlingen
76275
Germany

Sponsor type

Industry

Website

http://www.iso-arznei.de

Funders

Funder type

Industry

Funder name

ISO Arzneimittel GmbH & Co KG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes