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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033590
Receipt No. R000038308
Official scientific title of the study Effect of JINSHIHOUTOU for patients with Pulmonary Mycobacterium avian complex infection
Date of disclosure of the study information 2018/08/01
Last modified on 2018/08/01

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Basic information
Official scientific title of the study Effect of JINSHIHOUTOU for patients with Pulmonary Mycobacterium avian complex infection
Title of the study (Brief title) Effect of JINSHIHOUTOU for MAC patients
Region
Japan

Condition
Condition pulmonary Mycobacterium avian complex infection
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In MAC patients, we analyze on changes in physical findings with JINSIHOUTOU, and examine the difference between exacerbated patients and non-exacerbated patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes CAT score, body weight and NK cell activity on administration and 3 months later.
Key secondary outcomes Evaluation of exacerbation factors for exacerbation group and non-exacerbation group
Depression score by SDS, STAI
Chest CT findings
Evaluation of exacerbation factors for exacerbation group and non-exacerbation group
evaluation of safety

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
Medicine
Interventions/Control_1 JINSHIHOUTOU 9.0g/d (3M~2Y)
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.age between 20 and under 80
2.Gender: male and female
3.Outpatient only
4.Patients satisfying the diagnostic criteria for pulmonary MAC disease)
A.Clinical criteria (satisfy the following two)
1.Chest CT findings indicate nodular shadow or branched shadow, cavitary shadow, bronchiectasis findings.
2.Can exclude other diseases
B.Bacteriological criteria (satisfies one)
1.Culture positive with two or more different sputum
2.Positive cultures in one or more bronchial lavage fluids
3.For transbronchial lung biopsy or lung biopsy tissue, histology findings conformed with pulmonary MAC disease and at the same time tissue or bronchial lavage fluid or sputum one or more culture positive
The above A and B are satisfied.
5. Rifampicin, ethambutol, clarithromycin, streptomycin, kanamycin, rifabutin, sitafloxacin, levofloxacin were not administered more than 14 days.
6. Patients who got informed consent.
Key exclusion criteria 1.Rifampicin, ethambutol, clarithromycin, streptomycin, kanamycin, rifabutin, sitafloxacin, levofloxacin are administered
2.Treated for pulmonary tuberculosis
3.With hypokalemia
4.With heart failure
5.With drug hypersensitivity
6.Pregnant and lactating women
7.Patients who participated in other clinical trials within 4 months
8.In addition, patients who are judged inappropriate.
Target sample size 30

Research contact person
Name of lead principal investigator Yuko Waseda
Organization Faculty of Medical Sciences University of Fukui
Division name Third Department of Internal Medicine
Address 23-3 Matsuoka Shimoaizuki, Eiheiji, Yoshida-gun, Fukui
TEL 0776-61-8355
Email yuwaseda@gmail.com

Public contact
Name of contact person Yuko Waseda
Organization Faculty of Medical Sciences University of Fukui
Division name Third Department of Internal Medicine
Address 23-3 Matsuoka Shimoaizuki, Eiheiji, Yoshida-gun, Fukui
TEL 0776-61-8355
Homepage URL
Email yuwaseda@mgmail.com

Sponsor
Institute Faculty of Medical Sciences University of Fukui
Institute
Department

Funding Source
Organization aculty of Medical Sciences University of Fukui
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 福井大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 03 Month 01 Day
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 01 Day
Last modified on
2018 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038308

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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