Tabriz University of Medical Sciences trial of inpatient intravenous urographin plus corticosteroid versus outpatient oral corticosteroid therapy in the Sudden Sensorineural Hearing Loss
| ISRCTN | ISRCTN84083523 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84083523 |
| Protocol serial number | N/A |
| Sponsor | Tabriz University of Medical Sciences (TUMS) (Iran) |
| Funder | Tabriz University of Medical Sciences (TUMS) (Iran) |
- Submission date
- 11/08/2006
- Registration date
- 13/10/2006
- Last edited
- 02/09/2021
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Javad Totonchi
Scientific
Scientific
Daneshgah Street
Imam Hospital
ENT ward
Tabriz
0098411
Iran
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional, controlled clinical trial |
| Secondary study design | Non randomised study |
| Scientific title | Tabriz University of Medical Sciences trial of inpatient intravenous urographin plus corticosteroid versus outpatient oral corticosteroid therapy in the Sudden Sensorineural Hearing Loss |
| Study acronym | SSHL trial |
| Study objectives | Sudden Sensorineural Hearing Loss is a diagnosis typically made if there is a greater than 20 dB hearing loss over at least three frequencies on audiometric testing. Hypothesis: In-hospital and vigorous treatment with intravenous corticosteroid and urographin will improve the outcome of patients with a sudden sensorineural hearing loss when compared to an outpatient oral corticosteroid therapy. |
| Ethics approval(s) | Approved by the Institutional Board Review and Ethics Committee, a section of Research Deputy of Faculty of Medicine at Tabriz University of Medical Sciences (TUMS). |
| Health condition(s) or problem(s) studied | Sudden Sensorineural Hearing Loss |
| Intervention | The trial is not a randomised one, as we had two groups: those hospitalised and those managed on outpatient. Hospitalisation was made on the basis of patient's request. Inpatient group received intravenous corticosteroid and intravenous urographin, while outpatient group received oral corticosteroid. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Corticosteroid and urographin |
| Primary outcome measure(s) |
Hearing recovery as shown by pure tone average on audiogram. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 51 |
| Key inclusion criteria | 1. Aged over 12 years 2. A greater than 20 dB hearing loss over at least three frequencies on audiometric testing |
| Key exclusion criteria | 1. General medical condition necessitating a specific therapy 2. Incompliance to the medications |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- Iran
Study participating centre
Daneshgah Street
Tabriz
0098411
Iran
0098411
Iran
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 | 01/07/2008 | 02/09/2021 | Yes | No |
Editorial Notes
02/09/2021: Publication reference and total final enrolment added.
