Efficacy of EPs 7630 in acute non-streptococcal tonsillopharyngitis
| ISRCTN | ISRCTN03930168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03930168 |
| Protocol serial number | UM002 |
| Sponsor | ISO Arzneimittel GmbH & Co KG (Germany) |
| Funder | ISO Arzneimittel GmbH & Co KG |
- Submission date
- 14/06/2002
- Registration date
- 14/06/2002
- Last edited
- 02/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
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 | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | EPs 7630 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/1997 |
| Date of final enrolment | 30/04/1997 |
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 |
