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The Study of Wuling Capsule in Treatment Chronic Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03674853
Recruitment Status : Unknown
Verified May 2018 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Drug: Wuling Capsule Drug: Oryzanol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Wuling Capsule in the Treatment of Chronic Tinnitus With Emotional Disorder
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

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

Active Comparator: Oryzanol group
Patients who were treated with oryzanol
Drug: Oryzanol
take oryzanol in active comparator group for 2 months

Primary Outcome Measures :
  1. THI [ Time Frame: 8 weeks ]
    tinnitus handicap index

Secondary Outcome Measures :
  1. HAMA [ Time Frame: 8 weeks ]
    Hamilton anxiety scale

  2. HAMD [ Time Frame: 8 weeks ]
    Hamilton depression scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03674853

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Contact: Song Yongli, doctor +86 02984775386

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China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Song Yongli, doctor         
Sponsors and Collaborators
Xijing Hospital
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Study Chair: Zha Dingjun, doctor First Affiliated Hospital of Fourth Military Medical University
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Responsible Party: Xijing Hospital Identifier: NCT03674853    
Other Study ID Numbers: KY20172099-1
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents