The Study of Wuling Capsule in Treatment Chronic Tinnitus
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tinnitus, Subjective | Drug: Wuling Capsule Drug: Oryzanol | Phase 4 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Wuling Capsule group
Patients who were treated with Wuling Caspule
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Drug: Wuling Capsule
take Wuling Capsule in experiment group for 2 months |
Active Comparator: Oryzanol group
Patients who were treated with oryzanol
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Drug: Oryzanol
take oryzanol in active comparator group for 2 months |
- THI [ Time Frame: 8 weeks ]tinnitus handicap index
- HAMA [ Time Frame: 8 weeks ]Hamilton anxiety scale
- HAMD [ Time Frame: 8 weeks ]Hamilton depression scale

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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;

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
Contact: Song Yongli, doctor | +86 02984775386 | syljudy@163.com |
China, Shaanxi | |
Xijing Hospital | Recruiting |
Xi'an, Shaanxi, China, 710032 | |
Contact: Song Yongli, doctor |
Study Chair: | Zha Dingjun, doctor | First Affiliated Hospital of Fourth Military Medical University |
Responsible Party: | Xijing Hospital |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |
Gamma-oryzanol Anti-Ulcer Agents Gastrointestinal Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |