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

This study has been completed.
Sponsor:
Collaborator:
Beijing Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Jianping Jia, Beijing Administration of Traditional Chinese Medicine Bureau
ClinicalTrials.gov Identifier:
NCT01454726
First received: June 1, 2011
Last updated: November 23, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in Dizziness Handicap Inventory (DHI) Questionnaire Score [ Time Frame: 0 and 24 hours ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 1, 2011
Results First Received: January 3, 2012
Last Updated: November 23, 2012
Health Authority: China: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013