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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020822
Receipt No. R000024034
Scientific Title The safety and efficacy of AHCC for pulmonary MAC disease
Date of disclosure of the study information 2016/02/10
Last modified on 2018/03/29

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Basic information
Public title The safety and efficacy of AHCC for pulmonary MAC disease
Acronym AHCC for pulmonary MAC disease
Scientific Title The safety and efficacy of AHCC for pulmonary MAC disease
Scientific Title:Acronym AHCC for pulmonary MAC disease
Region
Japan

Condition
Condition Pulmonary MAC disease
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of AHCC for pulmonary MAC disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety
(Adeverse event at 2 weeks, 2 months, 4 months, and 6 months after start of AHCC)
Key secondary outcomes efficacy
(sputa examination, chest image, clinical symptom)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Active Hexose Correlated Compound (AHCC)
AHCC 1800mg/day (600mg x 3 times)
At least 2 weeks, at maximum 6 months
Interventions/Control_2
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 (1) Informed consent attained
(2) Treatble case for pulmonary MAC disease
(3) Age above 20 years old
(4) Confirmed diagnosis of pulmonay MAC diseases
Key exclusion criteria (1) Ever treated pulmonary MAC disease
(2) Impossibe for evaluation for drug efficacy
(3) pregnant, breat-feeding, possible pregant woman
(4) allergy for AHCC
(5) Inappropriate by decision of attending physician
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Fujita
Organization Fukuoka University Hospital
Division name Resipiratory Medicine
Zip code
Address 7-45-1 Nanakuma, Jonanku, Fukuoka
TEL 092-801-1011
Email mfujita@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Fujita
Organization Fukuoka University Hospital
Division name Resipiratory Medicine
Zip code
Address 7-45-1 Nanakuma, Jonanku, Fukuoka
TEL 092-801-1011
Homepage URL http://www.med.fukuoka-u.ac.jp/respiratory/
Email mfujita@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Hospital
Institute
Department

Funding Source
Organization Fukuoka University Hospital
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 福岡大学病院(福岡県)
福西会病院(福岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 10 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
2016 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 16 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 01 Day
Last modified on
2018 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024034

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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