NCT01454726

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 24, 2012

Completed
Last Updated

December 24, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

June 1, 2011

Results QC Date

January 3, 2012

Last Update Submit

November 23, 2012

Conditions

Keywords

DizzinessMeniere's diseaseDiaoshi Jifa therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

experimental group

EXPERIMENTAL

receiving both Diaoshi Jifa therapy and the Western medical treatment.

Other: Diaoshi Jifa therapy plus the Western medical treatment.

control group

OTHER

receiving the Western medical treatment alone.

Other: drug

Interventions

Diaoshi Jifa treatment

Also known as: Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po
experimental group
drugOTHER

the Western medical treatment alone.

Also known as: Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po
control group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with critical illness of internal medicine and surgery
  • Patients with spinal disease or other conditions that cannot receive manual treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuan Wu Hosipital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Meniere DiseaseDizziness

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Endolymphatic HydropsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Our study focused only on the effect of Diaoshi Jifa on Meniere's disease after one-time treatment. There still possibilities that after several days' treatment, both experimental and control groups have similar improvement in their DHI scores.

Results Point of Contact

Title
Dr. Jianping JIA
Organization
Xuan Wu Hospital of Capital Medical University

Study Officials

  • Jianping Jia, MD

    Beijing Xuan Wu Hosipital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2011

First Posted

October 19, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

December 24, 2012

Results First Posted

December 24, 2012

Record last verified: 2012-01

Locations