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Completed

NCT Number: NCT01454726

Clinical Trial of 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.

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Key information

Conditions

Meniere's Disease Dizziness Ear Diseases Endolymphatic Hydrops Labyrinth Diseases Meniere Disease Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Xuan Wu Hosipital

Beijing, Beijing Municipality, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diaoshi Jifa therapy plus the Western medical treatment.

Other

Diaoshi Jifa treatment

Other names: Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po

drug

Other

the Western medical treatment alone.

Other names: Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Beijing Administration of Traditional Chinese Medicine Bureau

Other Gov

Collaborators

  • Beijing Hospital of Traditional Chinese Medicine

Registry information

Official study title

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

Acronym: TCDMD

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 19, 2011
Registry last updated
Dec 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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