UMIN-CTR Clinical Trial

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

Contact us.