The Study of Wuling Capsule in Treatment Chronic Tinnitus

July 19, 2022 updated by: Xijing Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wuling Capsule group
Patients who were treated with Wuling Caspule
Drug: Wuling Capsule
take Wuling Capsule in experiment group for 2 months
Other Names:
  • Ginaton
Active Comparator: Oryzanol group
Patients who were treated with oryzanol
Drug: Oryzanol
take oryzanol in active comparator group for 2 months
Other Names:
  • Ginaton

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change of severity of tinnitus
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Hamilton anxiety scale is to evaluate the anxiety level
8 weeks
the change of depression level
Time Frame: 8 weeks
Hamilton depression scale is to evaluate the depression level
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Chair: Zha Dingjun, doctor, First Affiliated Hospital of Fourth Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2018

Primary Completion (Actual)

October 30, 2019

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

September 13, 2018

First Submitted That Met QC Criteria

September 14, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20172099-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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