UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046367 |
|---|---|
| Receipt number | R000052909 |
| Scientific Title | Clinical effectiveness of Ninjin'yoeito in Patients with Chronic Respiratory Diseases |
| Date of disclosure of the study information | 2021/12/13 |
| Last modified on | 2022/12/14 16:41:54 |
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Basic information
Public title
Clinical effectiveness of Ninjin'yoeito in Patients with Chronic Respiratory Diseases
Acronym
Clinical effectiveness of Ninjin'yoeito in Patients with Chronic Respiratory Diseases
Scientific Title
Clinical effectiveness of Ninjin'yoeito in Patients with Chronic Respiratory Diseases
Scientific Title:Acronym
Clinical effectiveness of Ninjin'yoeito in Patients with Chronic Respiratory Diseases
Region
| Japan |
Condition
Condition
Chronic Respiratory Diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical efficacy of Ninjin'yoeito in patients with chronic respiratory diseases (e.g. COPD and NTM) with symptoms such as decreased appetite and weight loss
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, fluid composition, blood biochemistry (TP, Alb, ChE) after 6 months of administration of Ninjin'yoeito
Key secondary outcomes
Grip strength, walking speed, questionnaire (frailty checklist)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Interventions/Control_2
Untreated
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
Patients with chronic respiratory diseases (e.g. COPD and NTM)
Key exclusion criteria
1) Under 20 years old
2) Pregnant women
3) Patients with concomitant diseases with poor prognosis (e.g., end-stage cancer, severe heart failure, liver cirrhosis, etc.)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Muraki |
Organization
Kindai Universuty Nara Hospital
Division name
Department of Respiratory Medicine and Allergology
Zip code
630-2093
Address
1248-1 Otoda-cho, Ikoma, Nara 603-0293, Japan
TEL
0743-77-0880
muraki-m@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Muraki |
Organization
Kindai Universuty Nara Hospital
Division name
Department of Respiratory Medicine and Allergology
Zip code
630-2093
Address
1248-1 Otoda-cho, Ikoma, Nara 603-0293, Japan
TEL
0743-77-0880
Homepage URL
muraki-m@med.kindai.ac.jp
Sponsor or person
Institute
Kindai Universuty
Institute
Department
Personal name
Funding Source
Organization
Kindai Universuty
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
Kindai Universuty Nara Hospital
Address
1248-1 Otoda-cho, Ikoma, Nara 603-0293, Japan
Tel
0743-77-0880
muraki-m@med.kindai.ac.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
近畿大学奈良病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 13 | 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
| 2021 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2031 | Year | 12 | 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
| 2021 | Year | 12 | Month | 13 | Day |
Last modified on
| 2022 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052909
