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
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