Tinnitus, SubjectiveNCT03674853

The Study of Wuling Capsule in Treatment Chronic Tinnitus

A study testing Wuling Capsule and Oryzanol in people with Tinnitus, Subjective, run by Xijing Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Tinnitus, Subjective
What is being tested?: Wuling Capsule and Oryzanol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteChina
Study dates: 12 Jun 2018to 30 Mar 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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;

Trial locations and contacts

1 site in 1 country.

China1 site

Xijing Hospital
Xi'an, Shaanxi, 710032

Other trials in China

About this study

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

Read the detailed description

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。

Conditions: Tinnitus, Subjective
Being tested: Wuling Capsule, Oryzanol
Medical subject headings: Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Wuling CapsuleDrug
Also called Ginaton
take Wuling Capsule in experiment group for 2 months
OryzanolDrug
Also called Ginaton
take oryzanol in active comparator group for 2 months

Study groups in NCT03674853
Study group	Role	What they receive
Wuling Capsule group	Experimental	Patients who were treated with Wuling Caspule Receives: Drug: Wuling Capsule
Oryzanol group	Active comparator	Patients who were treated with oryzanol Receives: Drug: Oryzanol

What is being measured

The primary outcome is the main question the study is designed to answer.

the change of severity of tinnitus
tinnitus handicap index is to evaluate the severity of tinnitus
Measured: 8 weeks

Secondary outcomes (2)

the change of anxiety level
Hamilton anxiety scale is to evaluate the anxiety level
Measured: 8 weeks
the change of depression level
Hamilton depression scale is to evaluate the depression level
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jun 201830 Mar 2020

First posted18 Sep 2018
Study start12 Jun 2018
Primary completion30 Oct 2019
Study completion30 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
More trials run by Xijing HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03674853
Sponsor's protocol ID: KY20172099-1
Status last verified: May 2022
First submitted: 13 Sep 2018
Last updated: 25 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
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Advanced Neurofeedback for Tinnitus
Tinnitus, Subjective
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Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus
Chronic Subjective Tinnitus
Recruiting
Non-Invasive Neurofeedback Training to Alleviate Tinnitus Distress
Tinnitus Aggravated, Tinnitus
Not yet recruiting
COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus

All Tinnitus, Subjective trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of Wuling Capsule in the Treatment of Chronic Tinnitus With Emotional Disorder
ClinicalTrials.gov ID: NCT03674853
Acronym / sponsor ID: KY20172099-1
Conditions: Tinnitus, Subjective
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Xijing HospitalUniversity, hospital or other
Study start: 12 Jun 2018 (actual)
Primary completion: 30 Oct 2019 (actual)
Study completion: 30 Mar 2020 (actual)
First posted: 18 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Wuling Capsule group	Experimental	Drug: Wuling CapsulePatients who were treated with Wuling Caspule
Oryzanol group	Active comparator	Drug: OryzanolPatients who were treated with oryzanol

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Wuling CapsuleAlso: Ginatontake Wuling Capsule in experiment group for 2 months	Drug	Wuling Capsule group
OryzanolAlso: Ginatontake oryzanol in active comparator group for 2 months	Drug	Oryzanol group

Primary outcome

the change of severity of tinnitus
Time frame: 8 weeks
tinnitus handicap index is to evaluate the severity of tinnitus

2 secondary outcomes

the change of anxiety level
Time frame: 8 weeks
the change of depression level
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
Individual participant dataSharing planned: No

Related trials for Tinnitus, Subjective

Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
Not yet recruiting
Advanced Neurofeedback for Tinnitus
Tinnitus, Subjective
Not yet recruiting
Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus
Chronic Subjective Tinnitus
Recruiting
Non-Invasive Neurofeedback Training to Alleviate Tinnitus Distress
Tinnitus Aggravated, Tinnitus
Not yet recruiting
COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zha Dingjun, doctor study chair

First Affiliated Hospital of Fourth Military Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Wuling Capsule and Oryzanol in people with Tinnitus, Subjective, run by Xijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the change of severity of tinnitus (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03674853.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.