UMIN-CTR Clinical Trial

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