Efficacy of EPs 7630 compared to N-acetylcysteine (ACC) in children with acute bronchitis

ISRCTN ISRCTN58336458
DOI https://doi.org/10.1186/ISRCTN58336458
Secondary identifying numbers UM009
Submission date
26/03/2003
Registration date
26/03/2003
Last edited
07/09/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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 bronchitis
Intervention215 Children were randomised to receive either:
1. Herbal remedy EPs 7630, 20 drops three times daily
2. ACC, 200 mg twice daily

The duration of individual treatment lasted over a maximum of 7 days.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)EPs 7630, N-acetylcysteine (ACC)
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 participants215
Key inclusion criteriaPatients who met the following inclusion criteria were suitable for the trial:
1. Age 6 - 12 years, acute bronchitis, duration of complaints less than 48 hours and total score of bronchitis-specific symptoms greater than or equal to 5 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