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Completed

NCT Number: NCT03674853

The Study of Wuling Capsule in Treatment Chronic Tinnitus

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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。

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Wuling Capsule

Drug

take Wuling Capsule in experiment group for 2 months

Other names: Ginaton

Oryzanol

Drug

take oryzanol in active comparator group for 2 months

Other names: Ginaton

Primary outcomes

  1. the change of severity of tinnitus

    Time frame: 8 weeks

    tinnitus handicap index is to evaluate the severity of tinnitus

Secondary outcomes

  1. the change of anxiety level

    Time frame: 8 weeks

    Hamilton anxiety scale is to evaluate the anxiety level

  2. the change of depression level

    Time frame: 8 weeks

    Hamilton depression scale is to evaluate the depression level

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 18, 2018
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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