UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047951 |
|---|---|
| Receipt number | R000054666 |
| Scientific Title | A Study of the Efficacy of Ninjin'yoeito in Patients with Pulmonary Non-tuberculous Mycobacterial Infection |
| Date of disclosure of the study information | 2022/06/07 |
| Last modified on | 2022/06/05 12:44:27 |
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Basic information
Public title
A Study of the Efficacy of Ninjin'yoeito in Patients with Pulmonary Non-tuberculous Mycobacterial Infection
Acronym
Efficacy of Ninjin'yoeito in PNTM
Scientific Title
A Study of the Efficacy of Ninjin'yoeito in Patients with Pulmonary Non-tuberculous Mycobacterial Infection
Scientific Title:Acronym
Efficacy of Ninjin'yoeito in PNTM
Region
| Japan |
Condition
Condition
Pulmonary non-tuberculousis mycobacteria
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the nutritional status, laboratory findings, and quality of life of patients with pulmonary non-tuberculous mycobacteriosis before and after (6 months) treatment with ginseng yoeito, and to compare the efficacy and safety of the treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kihon Check List score(KCL score)
Key secondary outcomes
CAT, imaging findings (chest X-ray, CT), bacteriological examination (sputum, etc.), laboratory values (CRP).
Blood pressure, AST, ALT, ALP total bilirubin, alubumin, creatinine, BUN, ganma-GTP, and Potassium
Urinalysis ; urine protein (qualitative)
Dietary intake (interview), cough-related QOL, simple nutritional status evaluation chart, body weight, clinical laboratory values (qualitative), Weight, laboratory values (WBC, RBC, Hb, TP, Alb)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ninjin'yoeito group
Interventions/Control_2
observation group
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) Patients with bacteriologically or clinically diagnosed pulmonary non-tuberculous mycobacteriosis
(2) Patients aged 20 years or older at the time of consent
(3) Patients with an ECOG performance status of 0 or 1
(4) Patients who fully understand and freely consent to participate in this study in writing.
Key exclusion criteria
(1) Patients with contraindications to the administration of Ninsin Yoeito
(2) Patients who are deemed inappropriate for this study by the physician in charge
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Sakurai |
Organization
Shizuoka General Hospital
Division name
Respiratory Medicine
Zip code
420-8527
Address
4-27-1 Kita-Ando, Aoi-ku, Shizuoka City, Shizuoka Prefecture
TEL
054-247-6111
shogo-sakurai@i.shizuoka-pho.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Sakurai |
Organization
Shizuoka General Hospital
Division name
Respiratory Medicine
Zip code
420-8527
Address
4-27-1 Kita-Ando, Aoi-ku, Shizuoka City, Shizuoka Prefecture
TEL
054-247-6111
Homepage URL
shogo-sakurai@i.shizuoka-pho.jp
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka General Hospital Clinical Research Ethics Committee
Address
4-27-1 Kita-Ando, Aoi-ku, Shizuoka City, Shizuoka Prefecture
Tel
054-247-6111
honbu-soumu@shizuoka-pho.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 07 | 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
| 2022 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 05 | Day |
Last modified on
| 2022 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054666
