The Study of Wuling Capsule in Treatment Chronic Tinnitus

Study Overview
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Brief Summary
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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
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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。

Official Title
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Clinical Study of Wuling Capsule in the Treatment of Chronic Tinnitus With Emotional Disorder

Conditions
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Tinnitus, Subjective

Intervention / Treatment
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* Drug: Wuling Capsule
* Drug: Oryzanol


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wuling Capsule group<br>Patients who were treated with Wuling Caspule | Drug: Wuling Capsule<br>* take Wuling Capsule in experiment group for 2 months<br>* Other names: Ginaton;|
| Active Comparator: Oryzanol group<br>Patients who were treated with oryzanol | Drug: Oryzanol<br>* take oryzanol in active comparator group for 2 months<br>* Other names: Ginaton;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of severity of tinnitus | tinnitus handicap index is to evaluate the severity of tinnitus | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of anxiety level | Hamilton anxiety scale is to evaluate the anxiety level | 8 weeks | 
| the change of depression level | Hamilton depression scale is to evaluate the depression level | 8 weeks |