UMIN-CTR Clinical Trial

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
Email	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
Email	harada.hiroaki.ue@mail.hosp.go.jp

Sponsor
Institute	Higashi-Hiroshima Medical Center, National Hospital Organization (Clinical Research Department)
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054569