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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000277
Receipt No. 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

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

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
URL(English) https://upload.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


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