Efficacy of hangekobokuto, a representative Kampo(Japanese herbal medicine) formula for Ki congestion, in tinnitus that continues for three months or more: A Randomized, Double-blind, Placebo-Controlled Trial.

Efficacy of hangekobokuto, a representative Kampo(Japanese herbal medicine) formula for Ki congestion, in tinnitus that continues for three months or more: A Randomized, Double-blind, Placebo-Controlled Trial. - Efficacy of hangekobokuto in tinnitus that continues for three months or more.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004766

Enrollment

112

Registered

2010-12-25

Start date

2011-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Interventions

Spray-dried tablet of hangekobokuto, 12 tablets per day Placebo tablet, 12 tablets per day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Tinnitus patients 1. Patients are conscious of tinnitus for three months or more. 2. Patients whose score in total is equal to or more than eighteen points in THI.

Exclusion criteria

Exclusion criteria: 1. Patients currently taking any Kampo medicine. 2. Patients having taken any Kampo medicine in the post 4 weeks. 3. Objective tinnitus, pulsatile tinnitus. 4. Patients whose air bone gap is equal to or more than 15dB. 5. Patients with clinically significant liver or renal dysfunction. 6. Patients while being getting pregnant and suckling. 7. Patients with some diseases which might influence there general condition, for example, cancer or heart failure. 8. Patients considered inappropriate for this trial by the physicians-in-charge.

Design outcomes

Primary

Measure	Time frame
THI(Tinnitus Handicap Inventory)	—

Secondary

Measure	Time frame
1. Pure Tone Audiometry 2. VAS(Visual Analogue Scale) 3. SF-36(MOS Short-Form 36-Item Health Survey) 4. HADS(Hospital Anxiety and Depression Scale)	—

Countries

Japan

Contacts

Public ContactTakeshi Ino

Oriental Medicine Research Center, Kitasato University Center for Evidence-Based Medicine

dm09005z@st.kitasato-u.ac.jp03-3444-6161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026