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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Tracking Information
First Submitted Date  ICMJE September 13, 2018
First Posted Date  ICMJE September 18, 2018
Last Update Posted Date September 18, 2018
Actual Study Start Date  ICMJE June 12, 2018
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
THI [ Time Frame: 8 weeks ]
tinnitus handicap index
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • HAMA [ Time Frame: 8 weeks ]
    Hamilton anxiety scale
  • HAMD [ Time Frame: 8 weeks ]
    Hamilton depression scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study of Wuling Capsule in Treatment Chronic Tinnitus
Official Title  ICMJE Clinical Study of Wuling Capsule in the Treatment of Chronic Tinnitus With Emotional Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus, Subjective
Intervention  ICMJE
  • Drug: Wuling Capsule
    take Wuling Capsule in experiment group for 2 months
  • Drug: Oryzanol
    take oryzanol in active comparator group for 2 months
Study Arms  ICMJE
  • Experimental: Wuling Capsule group
    Patients who were treated with Wuling Caspule
    Intervention: Drug: Wuling Capsule
  • Active Comparator: Oryzanol group
    Patients who were treated with oryzanol
    Intervention: Drug: Oryzanol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 14, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2019
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03674853
Other Study ID Numbers  ICMJE KY20172099-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zha Dingjun, doctor First Affiliated Hospital of Fourth Military Medical University
PRS Account Xijing Hospital
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP