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| Name | Class |
|---|---|
| Beijing Hospital of Traditional Chinese Medicine | OTHER |
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The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in patients with Meniere's disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | receiving both Diaoshi Jifa therapy and the Western medical treatment. |
|
| control group | Other | receiving the Western medical treatment alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaoshi Jifa therapy plus the Western medical treatment. | Other | Diaoshi Jifa treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianping Jia, MD | Beijing Xuan Wu Hosipital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuan Wu Hosipital | Beijing | Beijing Municipality | 100053 | China |
A total of 27 patients were enrolled and randomly attributed to either experimental or control group.
recruitment period: Jan 1, 2011-November 30, 2011 recruitment location: Department of Neurology, Xuan Wu Hospital of Capital Medical University
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group | receiving both Diaoshi Jifa therapy and the Western medical treatment. |
| FG001 | Control Group | receiving the Western medical treatment alone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group | receiving both Diaoshi Jifa therapy and the Western medical treatment. |
| BG001 | Control Group | receiving the Western medical treatment alone. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 0 and 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group | receiving both Diaoshi Jifa therapy and the Western medical treatment. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jianping JIA | Xuan Wu Hospital of Capital Medical University | 0086-10-83198899 | 8650 | jiajp@vip.sina.com |
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| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| D004244 | Dizziness |
| ID | Term |
|---|---|
| D018159 | Endolymphatic Hydrops |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| drug | Other | the Western medical treatment alone. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group | receiving the Western medical treatment alone. |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Control Group | receiving the Western medical treatment alone. | 0 | 10 | 0 | 10 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |