Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease
TCDMD
A Random Controlled Clinical Trial:l Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease
1 other identifier
interventional
27
1 country
1
Brief Summary
The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in patients with Meniere's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
October 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
December 24, 2012
CompletedDecember 24, 2012
January 1, 2012
10 months
June 1, 2011
January 3, 2012
November 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
0 and 24 hours
Study Arms (2)
experimental group
EXPERIMENTALreceiving both Diaoshi Jifa therapy and the Western medical treatment.
control group
OTHERreceiving the Western medical treatment alone.
Interventions
Diaoshi Jifa treatment
the Western medical treatment alone.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with critical illness of internal medicine and surgery
- Patients with spinal disease or other conditions that cannot receive manual treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuan Wu Hosipital
Beijing, Beijing Municipality, 100053, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. Jianping JIA
- Organization
- Xuan Wu Hospital of Capital Medical University
Study Officials
- PRINCIPAL INVESTIGATOR
Jianping Jia, MD
Beijing Xuan Wu Hosipital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 1, 2011
First Posted
October 19, 2011
Study Start
January 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
December 24, 2012
Results First Posted
December 24, 2012
Record last verified: 2012-01