UMIN-CTR Clinical Trial

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

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Basic information

Public 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.

Acronym

Efficacy of hangekobokuto in tinnitus that continues for three months or more.

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.

Scientific Title:Acronym

Efficacy of hangekobokuto in tinnitus that continues for three months or more.

Region

Japan


Condition

Condition

Tinnitus

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of hangekobokuto in tinnitus.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

THI(Tinnitus Handicap Inventory)

Key secondary outcomes

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)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Spray-dried tablet of hangekobokuto, 12 tablets per day

Interventions/Control_2

Placebo tablet, 12 tablets per day

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key 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.

Key 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.

Target sample size

112


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Ino

Organization

Kitasato University Hospital

Division name

Otorhinolaryngology

Zip code


Address

1-15-1, Kitasato, Minamiku, Sagamihara city, Kanagawa

TEL

042-778-8466

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Ino

Organization

Oriental Medicine Research Center, Kitasato University

Division name

Center for Evidence-Based Medicine

Zip code


Address

5-9-1, Shirokane, Minatoku, Tokyo

TEL

03-3444-6161

Homepage URL


Email

dm09005z@st.kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

北里大学病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2010 Year 12 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 11 Month 10 Day

Date of IRB


Anticipated trial start date

2011 Year 01 Month 01 Day

Last follow-up date

2012 Year 05 Month 01 Day

Date of closure to data entry

2012 Year 05 Month 01 Day

Date trial data considered complete

2012 Year 07 Month 01 Day

Date analysis concluded

2012 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 12 Month 21 Day

Last modified on

2012 Year 06 Month 25 Day



Link to view the page

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