The Study of Wuling Capsule in Treatment Chronic Tinnitus

Tinnitus, Subjective Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03674853
• Other study ID #: KY20172099-1
• Status: Completed
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: May 2022
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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。

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 30, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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;

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Drug:
• Wuling Capsule
take Wuling Capsule in experiment group for 2 months
• Oryzanol
take oryzanol in active comparator group for 2 months

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of severity of tinnitus	tinnitus handicap index is to evaluate the severity of tinnitus	8 weeks
Secondary	the change of anxiety level	Hamilton anxiety scale is to evaluate the anxiety level	8 weeks
Secondary	the change of depression level	Hamilton depression scale is to evaluate the depression level	8 weeks