The Study of Wuling Capsule in Treatment Chronic Tinnitus

Not Applicable

Completed

• Conditions: Tinnitus, Subjective
• Interventions: Drug: Wuling Capsule; Drug: Oryzanol

• Registration Number: NCT03674853
• Lead Sponsor: Xijing Hospital

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。

Study Timeline

• Study Start: 2018-06-12
• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-18
• Primary Completion: 2019-10-30
• Study Completion: 2020-03-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wuling Capsule group	Wuling Capsule	Patients who were treated with Wuling Caspule
Oryzanol group	Oryzanol	Patients who were treated with oryzanol

Primary Outcome Measures

Name	Time	Method
the change of severity of tinnitus	8 weeks	tinnitus handicap index is to evaluate the severity of tinnitus

Secondary Outcome Measures

Name	Time	Method
the change of anxiety level	8 weeks	Hamilton anxiety scale is to evaluate the anxiety level
the change of depression level	8 weeks	Hamilton depression scale is to evaluate the depression level

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China