NCT01574313

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
Last Updated

April 11, 2012

Status Verified

April 1, 2012

Enrollment Period

1 year

First QC Date

April 1, 2012

Last Update Submit

April 10, 2012

Conditions

VertigoMeniere Disease

Keywords

stellate ganglion block.Meniere's disease.electrocochleography.vertigo.hearing impairment.

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • SP/AP recorded at 4 hours after SGB

    4 hours after SGB

  • SP/AP recorded at 6 hours after SGB

    6 hours after SGB

  • scores of verbal scale for vertigo recorded at 6 hours after SGB

    6 hours after SGB

Study Arms (2)

Stellate ganglion block

EXPERIMENTAL

treated with SGB

Procedure: stellate ganglion block

Oral medication

ACTIVE COMPARATOR

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

Drug: 0.25mg, fludiazineDrug: 25mg cephadol@ (diphenidol)Drug: 200mg kentons@ (tocopherol nicotinate).

Interventions

stellate ganglion blockPROCEDURE

stellate ganglion block

Stellate ganglion block
0.25mg, fludiazineDRUG

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

Also known as: 0.25mg of erispan@
Oral medication
25mg cephadol@ (diphenidol)DRUG

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

Oral medication
200mg kentons@ (tocopherol nicotinate).DRUG

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

Oral medication

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients with coagulopathy,
  • arrhythmia,
  • myocardial ischemia,
  • glaucoma,
  • pregnant,
  • chronic otitis media or externa, and
  • past history of middle or inner ear surgery were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

i Mei Medical Center Tainan, Taiwan, Taiwan

Tainan, Tainan, 70014, Taiwan

Location

MeSH Terms

Conditions

VertigoMeniere DiseaseHearing Loss

Interventions

diphenidol

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsEndolymphatic HydropsHearing DisordersSensation Disorders

Study Officials

  • Yung-Song Lin, M.D.

    Chi Mei Medical Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of department of Otolaryngology

Study Record Dates

First Submitted

April 1, 2012

First Posted

April 10, 2012

Study Start

April 1, 2010

Primary Completion

April 1, 2011

Study Completion

March 1, 2012

Last Updated

April 11, 2012

Record last verified: 2012-04

Locations

TW(1)