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.
Phase 4
- Conditions
- Tinnitus
- Registration Number
- JPRN-UMIN000004766
- Lead Sponsor
- Kitasato University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 112
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method THI(Tinnitus Handicap Inventory)
- Secondary Outcome Measures
Name Time Method 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)