UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033590 |
|---|---|
| Receipt number | R000038308 |
| Scientific Title | 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 17:08:20 |
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Basic information
Public title
Effect of JINSHIHOUTOU for patients with Pulmonary Mycobacterium avian complex infection
Acronym
Effect of JINSHIHOUTOU for MAC patients
Scientific Title
Effect of JINSHIHOUTOU for patients with Pulmonary Mycobacterium avian complex infection
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yuko Waseda |
Organization
Faculty of Medical Sciences University of Fukui
Division name
Third Department of Internal Medicine
Zip code
Address
23-3 Matsuoka Shimoaizuki, Eiheiji, Yoshida-gun, Fukui
TEL
0776-61-8355
yuwaseda@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Waseda |
Organization
Faculty of Medical Sciences University of Fukui
Division name
Third Department of Internal Medicine
Zip code
Address
23-3 Matsuoka Shimoaizuki, Eiheiji, Yoshida-gun, Fukui
TEL
0776-61-8355
Homepage URL
yuwaseda@mgmail.com
Sponsor or person
Institute
Faculty of Medical Sciences University of Fukui
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038308
