chronic tinnitus
Conditions
Interventions
Oral administration of Tsumura Goshajinkigan (Traditional Japanese medicine: Kampo medicine) extract granule 7.5g daily in 3 divided doses (2.5g per packet 3 times a day) before each meal for 12 weeks
Sponsors
Okayasu Tadao
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with chronic tinnitus with a duration of illness of more than 3 months (diagnosis is made by interview. Unilateral or bilateral) 2) Patients aged 50 years and older 3) Performance Status (ECOG) of 0 or 1 4) Patients who have given their written consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1) Patients being treated with traditional Japanese medicines (Kanpo medicines) 2) Patients undergoing tinnitus acoustic therapy 3) Patients with tinnitus associated with hearing loss diseases such as sudden deafness, acute low-pitched sensorineural hearing loss, and Meniere's disease, and in the acute phase within 3 months of onset 4) Patients who have participated in other clinical trials within 3 months prior to the start of study drug administration 5) Patients with dementia (diagnosed with dementia or scoring 20 or less on the Hasegawa scale) 6) Patients with psychiatric diseases who require medication 7) Patients with liver diseases who require medication 8) Patients with interstitial pneumonia 9) Patients who are allergic to therapeutic agents 10) Pregnant patients or patients with possible pregnancy 11) Patients who are deemed inappropriate as research subjects by the principal investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparative change in tinnitus distress intensity score (THI) between enrollment and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from enrollment to 12 weeks for the following items -Pain severity of tinnitus (VAS) -Magnitude of tinnitus (VAS) -Duration of tinnitus (VAS) -Tinnitus (Loudness level) -Assessment of depression and anxiety (HADS) -Availability of indications for Goshajinkigan (Traditional Japanese medicine, Kampo medicine) Secular change in the following items -Tinnitus distress score (THI) -Pain severity of tinnitus (VAS) -Magnitude of tinnitus (VAS) -Duration of tinnitus (VAS) -Adverse event | — |
Contacts
Public ContactTadao Okayasu
Nara Medical University Hospital
Outcome results
None listed