UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047863 |
|---|---|
| Receipt number | R000054569 |
| Scientific Title | Evaluation of the effectiveness of complementary therapy with ninjinyoueito in the perioperative phase of pulmonary resection |
| Date of disclosure of the study information | 2022/12/31 |
| Last modified on | 2022/05/25 19:46:54 |
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Basic information
Public title
Evaluation of the effectiveness of complementary therapy with ninjinyoueito in the perioperative phase of pulmonary resection
Acronym
Evaluation of the efficacy of administration of herbal medicine in the perioperative phase of pulmonary resection
Scientific Title
Evaluation of the effectiveness of complementary therapy with ninjinyoueito in the perioperative phase of pulmonary resection
Scientific Title:Acronym
Ninjinyoueito test
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the clinical efficacy of the significance of using ninjinyoueito as a complementary therapy in the perioperative phase of lung resection surgery for lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL in the perioperative period
Key secondary outcomes
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
For patients who are scheduled to have lung cancer and have lung resection, take ginseng nourishment for about 2 to 4 weeks before surgery. While in the hospital, he continues to take internal medicine until he is discharged from the hospital. If possible, continue oral administration with six months of surgery as a guide. Evaluate the general condition, nutritional status, and postoperative course of the perioperative period.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for pulmonary resection for lung cancer
Key exclusion criteria
No disclaimer
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Harada |
Organization
National Hospital Organization Higashihiroshima Medical Center
Division name
Respiratory Surgery
Zip code
739-0041
Address
513, saijyo-tyo Jike, Higashihiroshima, Hiroshima
TEL
0824232176
harada.hiroaki.ue@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Harada |
Organization
National Hospital Organization Higashihiroshima Medical Center
Division name
Respiratory Surgery
Zip code
739-0041
Address
513, saijyo-tyo Jike, Higashihiroshima, Hiroshima
TEL
0824232176
Homepage URL
harada.hiroaki.ue@mail.hosp.go.jp
Sponsor or person
Institute
Higashi-Hiroshima Medical Center, National Hospital Organization (Clinical Research Department)
Institute
Department
Personal name
Funding Source
Organization
None
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
National Hospital Organization Higashihiroshima Medical Center
Address
513, saijyo-tyo Jike, Higashihiroshima, Hiroshima
Tel
0824232176
harada.hiroaki.ue@mail.hosp.go.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 | 12 | Month | 31 | 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
50
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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2022 | 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
| 2022 | Year | 05 | Month | 25 | Day |
Last modified on
| 2022 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054569
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
