Effect of Stellate Ganglion Block on Meniere's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-03-31

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Vertigo Meniere Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Stellate ganglion block

treated with SGB

Group Type EXPERIMENTAL

stellate ganglion block

Intervention Type PROCEDURE

stellate ganglion block

Oral medication

treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).

Group Type ACTIVE_COMPARATOR

0.25mg, fludiazine

Intervention Type DRUG

0.25mg of erispan@ (fludiazine), p.o. one dose only.

25mg cephadol@ (diphenidol)

Intervention Type DRUG

25mg cephadol@ (diphenidol) p.o. one dose only.

200mg kentons@ (tocopherol nicotinate).

Intervention Type DRUG

200mg kentons@ (tocopherol nicotinate) p.o. one dose only.

Interventions

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stellate ganglion block

Intervention Type PROCEDURE

0.25mg, fludiazine

0.25mg of erispan@ (fludiazine), p.o. one dose only.

Intervention Type DRUG

25mg cephadol@ (diphenidol)

25mg cephadol@ (diphenidol) p.o. one dose only.

Intervention Type DRUG

200mg kentons@ (tocopherol nicotinate).

200mg kentons@ (tocopherol nicotinate) p.o. one dose only.

Intervention Type DRUG

Other Intervention Names

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0.25mg of erispan@

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No