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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Meniere's Disease

Intervention / Treatment
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* Other: Diaoshi Jifa therapy plus the Western medical treatment.
* Other: drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients with critical illness of internal medicine and surgery Patients with spinal disease or other conditions that cannot receive manual treatment.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>receiving both Diaoshi Jifa therapy and the Western medical treatment. | Other: Diaoshi Jifa therapy plus the Western medical treatment.<br>* Diaoshi Jifa treatment<br>* Other names: Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po;|
| Other: control group<br>receiving the Western medical treatment alone. | Other: drug<br>* the Western medical treatment alone.<br>* Other names: Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dizziness, Meniere's disease, Diaoshi Jifa therapy