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

Phase 3

Completed

• Conditions: Meniere's Disease
• Interventions: Other: Diaoshi Jifa therapy plus the Western medical treatment.; Other: drug

• Registration Number: NCT01454726
• Lead Sponsor: Beijing Administration of Traditional Chinese Medicine Bureau

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-19
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-01
• Results First Submitted: 2012-01-03
• Results First Submitted QC: 2012-11-23
• Last Update Submitted: 2012-11-23
• Results First Posted: 2012-12-24
• Last Update Posted: 2012-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Diaoshi Jifa therapy plus the Western medical treatment.	receiving both Diaoshi Jifa therapy and the Western medical treatment.
control group	drug	receiving the Western medical treatment alone.

Primary Outcome Measures

Name	Time	Method
Change in Dizziness Handicap Inventory (DHI) Questionnaire Score	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.

Trial Locations

Locations (1)

Xuan Wu Hosipital; 🇨🇳 Beijing, Beijing, China