NCT03674853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

July 25, 2022

Status Verified

May 1, 2022

Enrollment Period

1.4 years

First QC Date

September 13, 2018

Last Update Submit

July 19, 2022

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (1)

  • the change of severity of tinnitus

    tinnitus handicap index is to evaluate the severity of tinnitus

    8 weeks

Secondary Outcomes (2)

  • the change of anxiety level

    8 weeks

  • the change of depression level

    8 weeks

Study Arms (2)

Wuling Capsule group

EXPERIMENTAL

Patients who were treated with Wuling Caspule

Drug: Wuling Capsule

Oryzanol group

ACTIVE COMPARATOR

Patients who were treated with oryzanol

Drug: Oryzanol

Interventions

Wuling CapsuleDRUG

take Wuling Capsule in experiment group for 2 months

Also known as: Ginaton
Wuling Capsule group
OryzanolDRUG

take oryzanol in active comparator group for 2 months

Also known as: Ginaton
Oryzanol group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Tinnitus with a history longer than 6 months;
  • \< HAMD score \< 24 and / or 7 \< HAMA score \< 21;
  • No antianxiety, depression or antipsychotic treatment within 2 weeks.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Tinnitus

Interventions

wulingginatongamma-oryzanol

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zha Dingjun, doctor

    First Affiliated Hospital of Fourth Military Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 18, 2018

Study Start

June 12, 2018

Primary Completion

October 30, 2019

Study Completion

March 30, 2020

Last Updated

July 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)