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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.
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。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wuling Capsule group | Experimental | Patients who were treated with Wuling Caspule |
|
| Oryzanol group | Active Comparator | Patients who were treated with oryzanol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wuling Capsule | Drug | take Wuling Capsule in experiment group for 2 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| the change of severity of tinnitus | tinnitus handicap index is to evaluate the severity of tinnitus | 8 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zha Dingjun, doctor | First Affiliated Hospital of Fourth Military Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| C533472 | wuling |
| C526713 | ginaton |
| C013172 | gamma-oryzanol |
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| Oryzanol | Drug | take oryzanol in active comparator group for 2 months |
|
|
| 8 weeks |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |