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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||||
Condition | Aspiration pneumonia | |||||
Classification by specialty |
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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 |
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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. | |
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Interventions/Control_8 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 | ||||||
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
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Last modified on |
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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 |