Efficacy of EPs 7630 compared to placebo in children with acute non-streptococcal tonsillopharyngitis
| ISRCTN | ISRCTN27398531 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27398531 |
| Protocol serial number | UM012 |
| 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
- 15/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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 tonsillopharyngitis |
| Intervention | 124 Children were randomised to receive either: 1. Herbal remedy EPs 7630, 20 drops three times daily 2. Placebo, 20 drops three times daily. The duration of individual treatment lasted over a maximum of 6 days. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 10 Years |
| Sex | All |
| Target sample size at registration | 124 |
| Key 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 hours, negative dip-and-react-test test for beta-hemolytic streptococcus and severity of symptoms greater than or equal to 8 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 | 01/06/2003 |
Locations
Countries of recruitment
- Germany
- Ukraine
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/09/2003 | Yes | No |
