Condition category
Ear, Nose and Throat
Date applied
14/06/2002
Date assigned
14/06/2002
Last edited
02/10/2007
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

UM002

Study information

Scientific title

Acronym

Study hypothesis

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.

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, non-streptococcal tonsillopharyngitis

Intervention

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.

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

01/03/1997

Overall trial end date

30/04/1997

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/1997

Recruitment end date

30/04/1997

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

Not defined

Funder name

ISO Arzneimittel GmbH & Co KG

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