Meniere's DiseasePhase 3TCDMDNCT01454726

Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease

A Phase 3 study testing Diaoshi Jifa therapy plus the Western medical treatment. and drug in people with Meniere's Disease, run by Beijing Administration of Traditional Chinese Medicine Bureau at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in patients with Meniere's disease. Read more about this study

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Meniere's Disease
What is being tested?: Diaoshi Jifa therapy plus the Western medical treatment. and drug
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteChina
Study dates: Jan 2011to Nov 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of probable Meniere's disease
Must be able to receive manual treatment
Dizziness Patients receiving other treatment longer than 5 days before entering the study.

Who cannot join

Patients with critical illness of internal medicine and surgery
Patients with spinal disease or other conditions that cannot receive manual treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

Xuan Wu Hosipital
Beijing, Beijing Municipality, 100053

Other trials in China

About this study

Official title: A Random Controlled Clinical Trial:l Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease

The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in patients with Meniere's disease.

Read the detailed description

Created by Dr. Diao, DiaoShi Jifa is a well-known traditional Chinese Medicine approach to treat dizziness in patients with chronic diseases. The investigators designed this randomized clinical trial to examine whether Diaoshi Jifa significantly decreases dizziness in patients with Meniere's disease. There are 2 arms in this trial: One arm is DiaoShi Jifa plus conventional Western medical treatment, another is conventional Western medical treatment only. The dizziness handicap inventory (DHI) will be used to evaluate the treatment effect.

Conditions: Meniere's Disease
Being tested: Diaoshi Jifa therapy plus the Western medical treatment., drug
Keywords: Dizziness, Meniere's disease, Diaoshi Jifa therapy
Medical subject headings: Meniere Disease, Dizziness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diaoshi Jifa therapy plus the Western medical treatment.Other
Also called Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po
Diaoshi Jifa treatment
drugOther
Also called Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po
the Western medical treatment alone.

Study groups in NCT01454726
Study group	Role	What they receive
experimental group	Experimental	receiving both Diaoshi Jifa therapy and the Western medical treatment. Receives: Other: Diaoshi Jifa therapy plus the Western medical treatment.
control group	Other	receiving the Western medical treatment alone. Receives: Other: drug

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Dizziness Handicap Inventory (DHI) Questionnaire Score
dizziness Handicap Inventory (DHI) evaluates the self-perceived handicapping effects imposed by vestibular system disease. We employed the final version of DHI, which contains 25 items including 7 physical questions, 9 functional questions and 9 emotional questions. DHI has a total score of 100 points (4 points for each item). Higher scores indicate more severe handicap. Thus the maximum score for DHI is 100, while the minimum core is 0.
Measured: 0 and 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Nov 2011

First posted19 Oct 2011 (estimated)
Study startJan 2011
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Meniere's DiseaseStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01454726
Sponsor's protocol ID: JJT2010-22
Acronym: TCDMD
Status last verified: Jan 2012
First submitted: 1 Jun 2011
Last updated: 24 Dec 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Active, not recruitingPhase 3
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Meniere's Disease, Ménière's Disease
RecruitingObservational study
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome
RecruitingPhase 4
Treatment of Meniere's Disease With Migraine Medications
Ménière
RecruitingPhase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Autoimmune Inner Ear Disease, Meniere's Disease

All Meniere's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Random Controlled Clinical Trial:l Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease
ClinicalTrials.gov ID: NCT01454726
Acronym / sponsor ID: TCDMD / JJT2010-22
Conditions: Meniere's Disease
Keywords: Dizziness, Meniere's disease, Diaoshi Jifa therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Beijing Administration of Traditional Chinese Medicine BureauOther government
Collaborators: Beijing Hospital of Traditional Chinese Medicine
Study start: Jan 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 19 Oct 2011 (estimated)
Results: Posted 24 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in patients with Meniere's disease.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
experimental group	Experimental	Other: Diaoshi Jifa therapy plus the Western medical treatment.receiving both Diaoshi Jifa therapy and the Western medical treatment.
control group	Other	Other: drugreceiving the Western medical treatment alone.

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Clinical diagnosis of probable Meniere's disease
Must be able to receive manual treatment
Dizziness Patients receiving other treatment longer than 5 days before entering the study.

Key exclusion criteria (2 listed)

Patients with critical illness of internal medicine and surgery
Patients with spinal disease or other conditions that cannot receive manual treatment.

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
Diaoshi Jifa therapy plus the Western medical treatment.Also: Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid poDiaoshi Jifa treatment	Other	experimental group
drugAlso: Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid pothe Western medical treatment alone.	Other	control group

Primary outcome

Change in Dizziness Handicap Inventory (DHI) Questionnaire Score
Time frame: 0 and 24 hours
dizziness Handicap Inventory (DHI) evaluates the self-perceived handicapping effects imposed by vestibular system disease. We employed the final version of DHI, which contains 25 items including 7 physical questions, 9 functional questions and 9 emotional questions. DHI has a total score of 100 points (4 points for each item). Higher scores indicate more severe handicap. Thus the maximum score for DHI is 100, while the minimum core is 0.

Results and safety

Results posted to the registry on 24 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Group	16	16
Control Group	11	10

Primary outcome: Change in Dizziness Handicap Inventory (DHI) Questionnaire Score

Time frame: 0 and 24 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Experimental Group n = 16	Control Group n = 10
Value	10.25 (9.77)	49.6 (20.50)

Population analysed: Among the 27 participants enrolled in the study, one participant quitted the study before treatment application. Twenty-six patients fulfilled all the procedures and were eligible for the full analysis.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Group	0 of 16 (0%)	0 of 16 (0%)	Not reported
Control Group	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): Our study focused only on the effect of Diaoshi Jifa on Meniere's disease after one-time treatment. There still possibilities that after several days' treatment, both experimental and control groups have similar improvement in their DHI scores.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Meniere's Disease

Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Active, not recruitingPhase 3
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Meniere's Disease, Ménière's Disease
RecruitingObservational study
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome
RecruitingPhase 4
Treatment of Meniere's Disease With Migraine Medications
Ménière
RecruitingPhase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Autoimmune Inner Ear Disease, Meniere's Disease

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.

Jianping Jia, MD principal investigator

Beijing Xuan Wu Hosipital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 2 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 24 Dec 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Dizziness Handicap Inventory (DHI) Questionnaire Score (time frame: 0 and 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01454726.

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 24 Dec 2012.