The Study of Wuling Capsule in Treatment Chronic Tinnitus

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Tinnitus, Subjective

Treatments: Drug: Wuling Capsule; Drug: Oryzanol

Study type: Interventional

Funder types: Other

Identifiers

NCT03674853

KY20172099-1

Details and patient eligibility

About

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.

Full 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。

Enrollment: 59 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

59 participants in 2 patient groups

Wuling Capsule group

Experimental group

Description:

Patients who were treated with Wuling Caspule

Treatment:

Drug: Wuling Capsule

Oryzanol group

Active Comparator group

Description:

Patients who were treated with oryzanol

Treatment:

Drug: Oryzanol