NIPH Clinical Trials Search

ESKARGOT Study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	chronic tinnitus
Date of first enrollment	15/12/2025
Target sample size	70
Countries of recruitment
Study type	Interventional
Intervention(s)	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.

Outcome(s)

Primary Outcome

Comparative change in tinnitus distress intensity score (THI) between enrollment and 12 weeks

Secondary Outcome

<Effectiveness Evaluation> 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) <Safety Evaluation> -Adverse event

Key inclusion & exclusion criteria

Age minimum	>= 50age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.