Efficacy of EPs 7630 compared to N-acetylcysteine (ACC) in children with acute bronchitis
| ISRCTN | ISRCTN58336458 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58336458 |
| Protocol serial number | UM009 |
| Sponsor | ISO Arzneimittel GmbH & Co KG (Germany) |
| Funder | ISO Arzneimittel GmbH & Co KG (Germany) |
- 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
Scientific
Director Research Center HomInt
PO Box 41 02 40
Karlsruhe
76202
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Acute bronchitis |
| Intervention | 215 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 type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | EPs 7630, N-acetylcysteine (ACC) |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 215 |
| Key inclusion criteria | Patients 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 criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- Germany
Study participating centre
Director Research Center HomInt
Karlsruhe
76202
Germany
76202
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
