VertigoPhase 4NCT01574313
Effect of Stellate Ganglion Block on Meniere's Disease
A Phase 4 study testing stellate ganglion block, 0.25mg, fludiazine and 25mg cephadol@ (diphenidol) in people with Vertigo and Meniere Disease, run by Chi Mei Medical Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Vertigo, Meniere Disease
- What is being tested?
- stellate ganglion block, 0.25mg, fludiazine and 25mg cephadol@ (diphenidol)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2010to Mar 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with unilateral Meniere's disease, according to the criteria of the American Academy of Otolaryngology-Head and Neck Surgery, AAO-HNS (1995)
Who cannot join
- patients with coagulopathy,
- arrhythmia,
- myocardial ischemia,
- glaucoma,
- pregnant,
- chronic otitis media or externa, and
- past history of middle or inner ear surgery were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed 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).
- Conditions
- Vertigo, Meniere Disease
- Being tested
- stellate ganglion block, 0.25mg, fludiazine, 25mg cephadol@ (diphenidol), 200mg kentons@ (tocopherol nicotinate).
- Keywords
- stellate ganglion block., Meniere's disease., electrocochleography., vertigo., hearing impairment.
- Medical subject headings
- Vertigo, Meniere Disease, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stellate ganglion blockProcedure or surgery
stellate ganglion block
0.25mg, fludiazineDrug
Also called 0.25mg of erispan@
0.25mg of erispan@ (fludiazine), p.o. one dose only.
25mg cephadol@ (diphenidol)Drug
25mg cephadol@ (diphenidol) p.o. one dose only.
200mg kentons@ (tocopherol nicotinate).Drug
200mg kentons@ (tocopherol nicotinate) p.o. one dose only.
| Study group | Role | What they receive |
|---|---|---|
| Stellate ganglion block | Experimental | treated with SGB Receives: 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). Receives: Drug: 0.25mg, fludiazine; Drug: 25mg cephadol@ (diphenidol); Drug: 200mg kentons@ (tocopherol nicotinate). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: ECoG was reorded 2 hours after SGB
Secondary outcomes (3)
SP/AP recorded at 4 hours after SGB
SP/AP recorded at 4 hours after SGB was compared with that of pretreatment with SGB
Measured: 4 hours after SGB
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
Measured: 6 hours after SGB
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
Measured: 6 hours after SGB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startApr 2010
- Primary completionApr 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chi Mei Medical Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yung-Song Lin, Chi Mei Medical Hospital
- Investigators
- Yung-Song Lin, M.D., Principal investigator, Chi Mei Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574313
- Sponsor's protocol ID
- SGB09804-003
- Other IDs
- CMH09804-003
- Status last verified
- Apr 2012
- First submitted
- 1 Apr 2012
- Last updated
- 11 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stellate Ganglion Block on Meniere's Disease
- ClinicalTrials.gov ID
- NCT01574313
- Acronym / sponsor ID
- SGB09804-003
- Conditions
- Vertigo, Meniere Disease
- Keywords
- stellate ganglion block., Meniere's disease., electrocochleography., vertigo., hearing impairment.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chi Mei Medical HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellate ganglion block | Experimental | Procedure: stellate ganglion blocktreated with SGB |
| Oral medication | Active comparator | Drug: 0.25mg, fludiazine, Drug: 25mg cephadol@ (diphenidol), Drug: 200mg kentons@ (tocopherol nicotinate).treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate). |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with unilateral Meniere's disease, according to the criteria of the American Academy of Otolaryngology-Head and Neck Surgery, AAO-HNS (1995)
Key exclusion criteria (7 listed)
- patients with coagulopathy,
- arrhythmia,
- myocardial ischemia,
- glaucoma,
- pregnant,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stellate ganglion blockstellate ganglion block | Procedure or surgery | Stellate ganglion block |
| 0.25mg, fludiazineAlso: 0.25mg of erispan@0.25mg of erispan@ (fludiazine), p.o. one dose only. | Drug | Oral medication |
| 25mg cephadol@ (diphenidol)25mg cephadol@ (diphenidol) p.o. one dose only. | Drug | Oral medication |
| 200mg kentons@ (tocopherol nicotinate).200mg kentons@ (tocopherol nicotinate) p.o. one dose only. | Drug | Oral medication |
Primary outcome
SP/AP of Electrocochleography
Time frame: ECoG was reorded 2 hours after SGB
SP/AP of ECoG was recorded 2 hours after SGB. to be compared with the SP/AP of ECoG recorded before treatment
3 secondary outcomes
SP/AP recorded at 4 hours after SGB
Time frame: 4 hours after SGB
SP/AP recorded at 6 hours after SGB
Time frame: 6 hours after SGB
scores of verbal scale for vertigo recorded at 6 hours after SGB
Time frame: 6 hours after SGB
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yung-Song Lin, M.D. principal investigator
Chi Mei Medical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing stellate ganglion block, 0.25mg, fludiazine and 25mg cephadol@ (diphenidol) in people with Vertigo and Meniere Disease, run by Chi Mei Medical Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SP/AP of Electrocochleography (time frame: ECoG was reorded 2 hours after SGB). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2012; AzTrials last refreshed its copy on 8 Nov 2026.