Back to resultsThe Study of Wuling Capsule in Treatment Chronic Tinnitus
Primary Purpose
Tinnitus, Subjective
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Wuling Capsule
Oryzanol
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus, Subjective
Eligibility Criteria
Inclusion Criteria:
- Tinnitus with a history longer than 6 months;
- 7 < HAMD score < 24 and / or 7 < HAMA score < 21;
- No antianxiety, depression or antipsychotic treatment within 2 weeks.
Exclusion Criteria:
- objective tinnitus;
- tinnitus with defined causes;
- accompanied with acute infection, acute trauma, perioperative, chronic disease in the acute stage;
- with mental illness family history;
- HAMD score greater than 24 points or HAMA score greater than 21 points;
Sites / Locations
- Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Wuling Capsule group
Oryzanol group
Arm Description
Patients who were treated with Wuling Caspule
Patients who were treated with oryzanol
Outcomes
Primary Outcome Measures
the change of severity of tinnitus
tinnitus handicap index is to evaluate the severity of tinnitus
Secondary Outcome Measures
the change of anxiety level
Hamilton anxiety scale is to evaluate the anxiety level
the change of depression level
Hamilton depression scale is to evaluate the depression level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03674853
Brief Title
The Study of Wuling Capsule in Treatment Chronic Tinnitus
Official Title
Clinical Study of Wuling Capsule in the Treatment of Chronic Tinnitus With Emotional Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
March 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effect of psychological/mental factors on the severity of subjective tinnitus, to observe the efficacy and safety of Wuling capsule in the treatment of chronic subjective tinnitus with emotional disorders, and to evaluate the control rate of tinnitus complications, such as depression, anxiety and insomnia, and the improvement of patients'quality of life.
Detailed Description
To evaluate the effect of psychological/mental factors on the severity of subjective tinnitus, to observe the efficacy and safety of Wuling capsule in the treatment of chronic subjective tinnitus with emotional disorders, and to evaluate the control rate of tinnitus complications, such as depression, anxiety and insomnia, and the improvement of patients'quality of life. Patients with chronic tinnitus complicated with mild to moderate anxiety or depression were randomly divided into two groups. The experimental group was given oral treatment with Wuling capsule, and the control group was given gurusu treatment. The improvement of tinnitus, sleep, anxiety and depression in patients was evaluated at 2,4 and 8 weeks after treatment, respectively, and the efficacy of Wuling capsule in improving tinnitus combined with anxiety, depression and tinnitus was analyzed。
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wuling Capsule group
Arm Type
Experimental
Arm Description
Patients who were treated with Wuling Caspule
Arm Title
Oryzanol group
Arm Type
Active Comparator
Arm Description
Patients who were treated with oryzanol
Intervention Type
Drug
Intervention Name(s)
Wuling Capsule
Other Intervention Name(s)
Ginaton
Intervention Description
take Wuling Capsule in experiment group for 2 months
Intervention Type
Drug
Intervention Name(s)
Oryzanol
Other Intervention Name(s)
Ginaton
Intervention Description
take oryzanol in active comparator group for 2 months
Primary Outcome Measure Information:
Title
the change of severity of tinnitus
Description
tinnitus handicap index is to evaluate the severity of tinnitus
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
the change of anxiety level
Description
Hamilton anxiety scale is to evaluate the anxiety level
Time Frame
8 weeks
Title
the change of depression level
Description
Hamilton depression scale is to evaluate the depression level
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Tinnitus with a history longer than 6 months;
7 < HAMD score < 24 and / or 7 < HAMA score < 21;
No antianxiety, depression or antipsychotic treatment within 2 weeks.
Exclusion Criteria:
objective tinnitus;
tinnitus with defined causes;
accompanied with acute infection, acute trauma, perioperative, chronic disease in the acute stage;
with mental illness family history;
HAMD score greater than 24 points or HAMA score greater than 21 points;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zha Dingjun, doctor
Organizational Affiliation
First Affiliated Hospital of Fourth Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Study of Wuling Capsule in Treatment Chronic Tinnitus
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