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Trial Outcomes & Findings for Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease (NCT NCT01454726)

NCT ID: NCT01454726

Last Updated: 2012-12-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

27 participants

Primary outcome timeframe

0 and 24 hours

Results posted on

2012-12-24

Participant Flow

recruitment period: Jan 1, 2011-November 30, 2011 recruitment location: Department of Neurology, Xuan Wu Hospital of Capital Medical University

A total of 27 patients were enrolled and randomly attributed to either experimental or control group.

Participant milestones

Participant milestones
Measure
Experimental Group
receiving both Diaoshi Jifa therapy and the Western medical treatment.
Control Group
receiving the Western medical treatment alone.
Overall Study
STARTED
16
11
Overall Study
COMPLETED
16
10
Overall Study
NOT COMPLETED
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Experimental Group
receiving both Diaoshi Jifa therapy and the Western medical treatment.
Control Group
receiving the Western medical treatment alone.
Overall Study
Withdrawal by Subject
0
1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Experimental Group
n=16 Participants
receiving both Diaoshi Jifa therapy and the Western medical treatment.
Control Group
n=11 Participants
receiving the Western medical treatment alone.
Total
n=27 Participants
Total of all reporting groups
Age, Categorical
<=18 years
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=5 Participants
10 Participants
n=7 Participants
24 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Age Continuous
49.75 years
STANDARD_DEVIATION 12.63 • n=5 Participants
54.00 years
STANDARD_DEVIATION 8.91 • n=7 Participants
51.48 years
STANDARD_DEVIATION 11.27 • n=5 Participants
Sex: Female, Male
Female
11 Participants
n=5 Participants
5 Participants
n=7 Participants
16 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
6 Participants
n=7 Participants
11 Participants
n=5 Participants
Region of Enrollment
China
16 participants
n=5 Participants
11 participants
n=7 Participants
27 participants
n=5 Participants

PRIMARY outcome

Timeframe: 0 and 24 hours

Population: Among the 27 participants enrolled in the study, one participant quitted the study before treatment application. Twenty-six patients fulfilled all the procedures and were eligible for the full analysis.

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.

Outcome measures

Outcome measures
Measure
Experimental Group
n=16 Participants
receiving both Diaoshi Jifa therapy and the Western medical treatment.
Control Group
n=10 Participants
receiving the Western medical treatment alone.
Change in Dizziness Handicap Inventory (DHI) Questionnaire Score
10.25 units on a scale
Standard Deviation 9.77
49.6 units on a scale
Standard Deviation 20.50

Adverse Events

Experimental Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jianping JIA

Xuan Wu Hospital of Capital Medical University

Phone: 0086-10-83198899

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place