Tinnitus Ear, Nose and Throat Other disorders of ear, not elsewhere classified
Conditions
Interventions
This study is a randomised, double-blind, placebo-controlled study. Participants will receive bojungikgitang, banhabaekchulchonmatang, or a placebo-drug for 8 weeks. Oral administration occurs accordi
they take a packet of the medicine (12.52 g) with tepid water for three times a day after meal
2. Patients in group 2 receive banhabaekchulchonmatang and instructions on how to make a tea
they take a packet of the medicine (12.52 g) with tepid water for three times a day after meal
3. Patients in group 3 receive the placebo medicine (powdered extract), used in the same way as with grou
Sponsors
Korea Health Industry Development Institute (KHIDI) (South Korea)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Tinnitus Handicap Inventory (THI): the purpose of this questionnaire is to identify difficulties that may be experienced because of tinnitus: 1.1. F: Functional subscale (11 factors) 1.2. E: Emotional subscale (9 factors) 1.3. C: Catastrophic subscale (5 factors) 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) Safety: 1. Complete blood cell count, erythrocyte sedimentation rate (ESR) 2. Blood chemistry 3. Urine analysis 4. Chest antero-posterior (PA) film Measured at baseline, 8 weeks later of the first medication 5. Brain computed tomography (CT) 6. Otologic examination Measured at baseline 7. Vital signs; measured at baseline, treatment initiation, 4 weeks later of the first medication, 8 weeks later of the first medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1. Acoustic Examination (AE) 2. Visual Analogue Scale (VAS) 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) 3. EQ-5D 4. Health Utilities Index Mark 3 (HUI3) Measured at baseline, 8 weeks later of the first medication, follow up | — |
Countries
Korea, South
Outcome results
None listed