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The Study of Wuling Capsule in Treatment Chronic Tinnitus

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ClinicalTrials.gov Identifier: NCT03674853
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Study Description
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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

Study Design
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Study Type : Interventional
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

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03674853


Contacts
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Contact: Song Yongli, doctor +86 02984775386 syljudy@163.com

Locations
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China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Song Yongli, doctor         
Sponsors and Collaborators
Xijing Hospital
Investigators
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Study Chair: Zha Dingjun, doctor First Affiliated Hospital of Fourth Military Medical University
More Information
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03674853     History of Changes
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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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Gamma-oryzanol
Anti-Ulcer Agents
Gastrointestinal Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents