A clinical study of bojungikgitang and banhabaekchulchonmatang in adult tinnitus patients

Completed

Conditions: Tinnitus
Ear, Nose and Throat
Other disorders of ear, not elsewhere classified

Registration Number: ISRCTN23691284

Lead Sponsor: Korea Health Industry Development Institute (KHIDI) (South Korea)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

1. Age greater than 19 years, either sex
2. Typical conditions of intermittent or continuous tinnitus
2.1. The duration of more than 3 months
2.2. Involuntary perception of the concept of a sound without the presence of an external source
3. Agreed not to receive another treatment during the clinical trial period
4. Written and informed consent

Exclusion Criteria

1. Receiving other forms of tinnitus treatments
2. Underlying disease or history:
2.1. Otitis media
2.2. Acoustic tumour
2.3. Intracranial lesion
2.4. Inner ear malformation
2.5. Head trauma
2.6. Ototoxic drug medication, etc.
3. Women in pregnacy and lactation or without contraception
4. Other clinical trial within the last 1 month
5. Auditory surgery, a major surgery or a blood transfusion within the last 1 month
6. Hypersensitiveness or allergy of drugs
7. Disease which can affect the absorption of drugs or disordered digestion after surgery related to the disease
8. History of neuropsychitric abnormality:
8.1. Manic-depression
8.2. Schizophrenia
8.3. Alcoholism
8.4. Drug addiction, etc.
9. Cannot understand a written consent or follow this study:
9.1. Mental retardation
9.2. Mental or emotional problems
10. Judged by expert that they are inappropriate to participate in this study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy:<br>Tinnitus Handicap Inventory (THI): the purpose of this questionnaire is to identify difficulties that may be experienced because of tinnitus:<br>1.1. F: Functional subscale (11 factors)<br>1.2. E: Emotional subscale (9 factors)<br>1.3. C: Catastrophic subscale (5 factors)<br>Measured at baseline (1 week before treatment initiation), 4 weeks later of the first medication, 8 weeks later of the first medication, follow up (2 weeks later of treatment period)<br><br>Safety:<br>1. Complete blood cell count, erythrocyte sedimentation rate (ESR)<br>2. Blood chemistry<br>3. Urine analysis<br>4. Chest antero-posterior (PA) film<br>Measured at baseline, 8 weeks later of the first medication<br><br>5. Brain computed tomography (CT)<br>6. Otologic examination <br>Measured at baseline<br><br>7. Vital signs; measured at baseline, treatment initiation, 4 weeks later of the first medication, 8 weeks later of the first medication

Secondary Outcome Measures

Name	Time	Method
Efficacy:<br>1. Acoustic Examination (AE)<br>2. Visual Analogue Scale (VAS)<br>Measured at baseline (1 week before treatment initiation), 4 weeks later of the first medication, 8 weeks later of the first medication, follow up (2 weeks later of treatment period)<br><br>3. EQ-5D <br>4. Health Utilities Index Mark 3 (HUI3)<br>Measured at baseline, 8 weeks later of the first medication, follow up