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

November 23, 2012 updated by: Jianping Jia, Beijing Administration of Traditional Chinese Medicine Bureau

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

The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in patients with Meniere's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Xuan Wu Hosipital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po
Other: control group
receiving the Western medical treatment alone.
Other: drug
the Western medical treatment alone.
Other Names:
  • Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Administration of Traditional Chinese Medicine Bureau

Collaborators

Beijing Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Jianping Jia, MD, Beijing Xuan Wu Hosipital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

June 1, 2011

First Submitted That Met QC Criteria

October 17, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Estimate)

December 24, 2012

Last Update Submitted That Met QC Criteria

November 23, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JJT2010-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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