The Study of Wuling Capsule in Treatment Chronic Tinnitus

NCT ID: NCT03674853

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-12
• Study Completion Date: 2020-03-30

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。

Conditions

Tinnitus, Subjective

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Wuling Capsule group

Patients who were treated with Wuling Caspule

Group Type: EXPERIMENTAL

Wuling Capsule

Intervention Type: DRUG

take Wuling Capsule in experiment group for 2 months

Oryzanol group

Patients who were treated with oryzanol

Group Type: ACTIVE_COMPARATOR

Oryzanol

Intervention Type: DRUG

take oryzanol in active comparator group for 2 months

Interventions

Wuling Capsule

take Wuling Capsule in experiment group for 2 months

Intervention Type: DRUG

Oryzanol

take oryzanol in active comparator group for 2 months

Intervention Type: DRUG

Other Intervention Names

Ginaton; Ginaton

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zha Dingjun, doctor

Role: STUDY_CHAIR

First Affiliated Hospital of Fourth Military Medical University

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

KY20172099-1

Identifier Type: -

Identifier Source: org_study_id