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

Meniere's Disease Clinical Trial

— TCDMD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454726
• Other study ID #: JJT2010-22
• Status: Completed
• Phase: Phase 3
• First received: June 1, 2011
• Last updated: November 23, 2012
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Beijing Administration of Traditional Chinese Medicine Bureau
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

Other:
• Diaoshi Jifa therapy plus the Western medical treatment.
Diaoshi Jifa treatment
• drug
the Western medical treatment alone.

Locations

Country	Name	City	State
China	Xuan Wu Hosipital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Administration of Traditional Chinese Medicine Bureau	Beijing Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Dizziness Handicap Inventory (DHI) Questionnaire Score	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	No