Unique ID issued by UMIN | UMIN000004766 |
---|---|
Receipt number | R000005672 |
Scientific Title | 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. |
Date of disclosure of the study information | 2010/12/25 |
Last modified on | 2012/06/25 09:34:51 |
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.
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.
Japan |
Tinnitus
Oto-rhino-laryngology |
Others
NO
To evaluate the efficacy of hangekobokuto in tinnitus.
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
THI(Tinnitus Handicap Inventory)
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)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
Spray-dried tablet of hangekobokuto, 12 tablets per day
Placebo tablet, 12 tablets per day
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
112
1st name | |
Middle name | |
Last name | Takeshi Ino |
Kitasato University Hospital
Otorhinolaryngology
1-15-1, Kitasato, Minamiku, Sagamihara city, Kanagawa
042-778-8466
1st name | |
Middle name | |
Last name | Takeshi Ino |
Oriental Medicine Research Center, Kitasato University
Center for Evidence-Based Medicine
5-9-1, Shirokane, Minatoku, Tokyo
03-3444-6161
dm09005z@st.kitasato-u.ac.jp
Kitasato University Hospital
None
Self funding
NO
北里大学病院(神奈川県)
2010 | Year | 12 | Month | 25 | Day |
Unpublished
Completed
2010 | Year | 11 | Month | 10 | Day |
2011 | Year | 01 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2012 | Year | 07 | Month | 01 | Day |
2012 | Year | 10 | Month | 01 | Day |
2010 | Year | 12 | Month | 21 | Day |
2012 | Year | 06 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005672
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |