UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000277
Receipt number R000000351
Scientific Title A single blind, multi centered randomized control trial to investigate prevention effect of traditional Chinese herbal medicine Banxia Houpu Tang on the aspiration pneumonia in elderly.
Date of disclosure of the study information 2005/11/08
Last modified on 2010/09/22 02:34:01

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Basic information

Public title

A single blind, multi centered randomized control trial to investigate prevention effect of traditional Chinese herbal medicine Banxia Houpu Tang on the aspiration pneumonia in elderly.

Acronym

A traditional Chinese herbal medicine Banxia Houpu Tang prevents aspiration pneumonia in elderly

Scientific Title

A single blind, multi centered randomized control trial to investigate prevention effect of traditional Chinese herbal medicine Banxia Houpu Tang on the aspiration pneumonia in elderly.

Scientific Title:Acronym

A traditional Chinese herbal medicine Banxia Houpu Tang prevents aspiration pneumonia in elderly

Region

Japan


Condition

Condition

Aspiration pneumonia

Classification by specialty

Medicine in general Pneumology Neurology
Infectious disease Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We randomely devide elderly patients who have cerebral vascular diseases and other condition causing swallowing disorder or past history of aspiration pneumonia, and treat with Banxia Houpu Tang (BHT) and compare the frequency of aspiration pneumonia to whom took conventional therapy. Also, we compare the survival rate, ADL change, medical cost between the two groups.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II,III


Assessment

Primary outcomes

Frequency of aspiration pneumonia, survival rate, amount of eating meals, whole ADL level, medical cost

Key secondary outcomes

Cognition


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Patients in active treatment group took 7.5g BHT extract each day, 3 times before meal, one year (from March 2005 to Feb. 2006). They also took all known conventional therapies including swallowing training, ACE inhibitors, and rehabilitation.

Interventions/Control_2

Patient in control group took conventional therapies same as above.

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Elderly patients who have cerebro-vascular disorder and any conditions causeing swallowing disorder. Patient who have past history of aspiration pneumonia.

Key exclusion criteria

Patients who have chronic lung diseases, malignancies, immunodeficiency i.e. HIV infection, who has severe liver disfunction, severe renal disfunction, ischemic heart diseases, Patients who took other Chinese herbal medicines. Patients who can not take BHT per os.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koh Iwasaki

Organization

Tohoku University, post graduate school of medicine

Division name

Division of Geriatrics and Complementary medicine

Zip code


Address

Seiryo-machi 1-1, Aoba Ward, Sendai City, Miyagi Pref. Japan

TEL

022-717-7182

Email



Public contact

Name of contact person

1st name
Middle name
Last name Koh Iwasaki

Organization

Tohoku University, post graduate school of medicine

Division name

Division of Geriatrics and Complementary medicine

Zip code


Address

Seiryo-machi 1-1, Aoba Ward, Sendai City, Miyagi Pref. Japan

TEL

022-717-7182

Homepage URL


Email

QFG03604@nifty.com


Sponsor or person

Institute

Division of Geriatrics and Complementary medicine, Tohoku University, post graduate school of medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


Other related organizations

Co-sponsor

Utsunomiya-Higashi Hospital

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



Other administrative information

Date of disclosure of the study information

2005 Year 11 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

J Am Geriatr Soc. 2007 Dec;55(12):2035-40. Epub 2007 Oct 18.

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

2004 Year 12 Month 29 Day

Date of IRB


Anticipated trial start date

2005 Year 01 Month 01 Day

Last follow-up date

2006 Year 02 Month 01 Day

Date of closure to data entry

2006 Year 03 Month 01 Day

Date trial data considered complete

2006 Year 03 Month 01 Day

Date analysis concluded

2006 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 11 Month 04 Day

Last modified on

2010 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000351


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name