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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01574313
Other study ID # SGB09804-003
Secondary ID CMH09804-003
Status Completed
Phase Phase 4
First received April 1, 2012
Last updated April 10, 2012
Start date April 2010
Est. completion date March 2012

Study information

Verified date April 2012
Source Chi Mei Medical Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

Stellate ganglion block (SGB) has been the alternative treatment of Meniere's disease for years. However, objective evidence of the effect of SGB was still lack. The investigators conducted a randomized controlled study to examine the immediate effects of SGB in SP/AP of electrocochleography (ECoG).


Description:

Ten patients were randomly assigned to receive stellate ganglion block. These ten patients made up the experimental group. Another ten patients in the control group were assigned to receiving one dosage of oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 2012
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria:

- patients diagnosed with unilateral Meniere's disease, according to the criteria of the American Academy of Otolaryngology-Head and Neck Surgery, AAO-HNS (1995)

Exclusion Criteria:

- patients with coagulopathy,

- arrhythmia,

- myocardial ischemia,

- glaucoma,

- pregnant,

- chronic otitis media or externa, and

- past history of middle or inner ear surgery were excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
stellate ganglion block
stellate ganglion block
Drug:
0.25mg, fludiazine
0.25mg of erispan@ (fludiazine), p.o. one dose only.
25mg cephadol@ (diphenidol)
25mg cephadol@ (diphenidol) p.o. one dose only.
200mg kentons@ (tocopherol nicotinate).
200mg kentons@ (tocopherol nicotinate) p.o. one dose only.

Locations

Country Name City State
Taiwan i Mei Medical Center Tainan, Taiwan, Taiwan Tainan

Sponsors (1)

Lead Sponsor Collaborator
Chi Mei Medical Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary SP/AP of Electrocochleography SP/AP of ECoG was recorded 2 hours after SGB. to be compared with the SP/AP of ECoG recorded before treatment ECoG was reorded 2 hours after SGB No
Secondary SP/AP recorded at 4 hours after SGB SP/AP recorded at 4 hours after SGB was compared with that of pretreatment with SGB 4 hours after SGB No
Secondary SP/AP recorded at 6 hours after SGB SP/AP recorded at 4 hours after SGB was compared with the SP/AP recorded before SGB 6 hours after SGB No
Secondary scores of verbal scale for vertigo recorded at 6 hours after SGB scores of verbal scale for vertigo recorded at 6 hours after SGB was compared to the scores recorded before SGB 6 hours after SGB No
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