Back to resultsClinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease (TCDMD)
Primary Purpose
Meniere's Disease
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Diaoshi Jifa therapy plus the Western medical treatment.
drug
Sponsored by
About this trial
This is an interventional treatment trial for Meniere's Disease focused on measuring Dizziness, Meniere's disease, Diaoshi Jifa therapy
Eligibility Criteria
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.
Sites / Locations
- Xuan Wu Hosipital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
experimental group
control group
Arm Description
receiving both Diaoshi Jifa therapy and the Western medical treatment.
receiving the Western medical treatment alone.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01454726
First Posted
June 1, 2011
Last Updated
November 23, 2012
Sponsor
Beijing Administration of Traditional Chinese Medicine Bureau
Collaborators
Beijing Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01454726
Brief Title
Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease
Acronym
TCDMD
Official Title
A Random Controlled Clinical Trial:l Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Administration of Traditional Chinese Medicine Bureau
Collaborators
Beijing Hospital of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in patients with Meniere's disease.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
Keywords
Dizziness, Meniere's disease, Diaoshi Jifa therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
receiving both Diaoshi Jifa therapy and the Western medical treatment.
Arm Title
control group
Arm Type
Other
Arm Description
receiving the Western medical treatment alone.
Intervention Type
Other
Intervention Name(s)
Diaoshi Jifa therapy plus the Western medical treatment.
Other Intervention Name(s)
Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po
Intervention Description
Diaoshi Jifa treatment
Intervention Type
Other
Intervention Name(s)
drug
Other Intervention Name(s)
Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po
Intervention Description
the Western medical treatment alone.
Primary Outcome Measure Information:
Title
Change in Dizziness Handicap Inventory (DHI) Questionnaire Score
Description
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.
Time Frame
0 and 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianping Jia, MD
Organizational Affiliation
Beijing Xuan Wu Hosipital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuan Wu Hosipital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease
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