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Trial record 5 of 33 for:    "Meniere disease"

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01454726
First Posted: October 19, 2011
Last Update Posted: December 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beijing Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Jianping Jia, Beijing Administration of Traditional Chinese Medicine Bureau
  Purpose
The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in patients with Meniere's disease.

Condition Intervention Phase
Meniere's Disease Other: Diaoshi Jifa therapy plus the Western medical treatment. Other: drug Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Random Controlled Clinical Trial:l Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease

Resource links provided by NLM:


Further study details as provided by Jianping Jia, Beijing Administration of Traditional Chinese Medicine Bureau:

Primary Outcome Measures:
  • 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.


Enrollment: 27
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental group
receiving both Diaoshi Jifa therapy and the Western medical treatment.
Other: Diaoshi Jifa therapy plus the Western medical treatment.
Diaoshi Jifa treatment
Other Name: Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po
control group
receiving the Western medical treatment alone.
Other: drug
the Western medical treatment alone.
Other Name: Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with critical illness of internal medicine and surgery
  2. Patients with spinal disease or other conditions that cannot receive manual treatment.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454726


Locations
China, Beijing
Xuan Wu Hosipital
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Beijing Administration of Traditional Chinese Medicine Bureau
Beijing Hospital of Traditional Chinese Medicine
Investigators
Principal Investigator: Jianping Jia, MD Beijing Xuan Wu Hosipital
  More Information

Responsible Party: Jianping Jia, Professor, Beijing Administration of Traditional Chinese Medicine Bureau
ClinicalTrials.gov Identifier: NCT01454726     History of Changes
Other Study ID Numbers: JJT2010-22
First Submitted: June 1, 2011
First Posted: October 19, 2011
Results First Submitted: January 3, 2012
Results First Posted: December 24, 2012
Last Update Posted: December 24, 2012
Last Verified: January 2012

Keywords provided by Jianping Jia, Beijing Administration of Traditional Chinese Medicine Bureau:
Dizziness
Meniere's disease
Diaoshi Jifa therapy

Additional relevant MeSH terms:
Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases