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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034613
Receipt No. R000039464
Scientific Title The Exploratory Study about Efficacy and Safety of Ninjin'yoeito for Fatigue and Malaise Expressed in Postoperative Patients with Colorectal Cancer
Date of disclosure of the study information 2018/11/15
Last modified on 2018/10/24

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Basic information
Public title The Exploratory Study about Efficacy and Safety of Ninjin'yoeito for Fatigue and Malaise Expressed in Postoperative Patients with Colorectal Cancer
Acronym The Exploratory Study about Efficacy and Safety of Ninjin'yoeito in Postoperative Patients with Colorectal Cancer
Scientific Title The Exploratory Study about Efficacy and Safety of Ninjin'yoeito for Fatigue and Malaise Expressed in Postoperative Patients with Colorectal Cancer
Scientific Title:Acronym The Exploratory Study about Efficacy and Safety of Ninjin'yoeito in Postoperative Patients with Colorectal Cancer
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and safety of Ninjin'yoeito for fatigue and malaise expressed in postoperative elderly patients with colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fatigue and Malaise: The Evaluation by Chaludder fatigue questionnaire
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 The administration of Ninjin'yoeito
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
80 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with resected colorectal cancer (clinical stage I to IIIb)
2) Patients with Grade 1 or higherfatigue or malaise after surgery (CTCAE ver. 4.0)
3) Patients with ECOG PS 0 to 2
4) Patients whose main organ functions are adequately maintained
5) Age: over 80 years old (when acquiring consent)
6) Category of examination: Outpatient and hospitalization
7) Patients who can be orally administered
8) Patients who wrote consent form to participate in this study
Key exclusion criteria 1) Patients with active other cancers
2) Patients with severe complications (such as liver disease, renal disease, heart disease, blood disease or metabolic disease) or mental disease
3) Patients taking drugs banned in this study or Ninjin'yoeito within 4 weeks before the start of the study
4) Patients who have a history of allergies to traditional Chinese medicine
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujii Tsutomu
Organization Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Division name Department of Surgery and Science
Zip code
Address 2630, Sugitani, Toyama
TEL 076-434-7331
Email surgery2@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Baba Hayato
Organization Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Division name Department of Surgery and Science
Zip code
Address 2630, Sugitani, Toyama
TEL 076-434-7331
Homepage URL
Email hayato.bb@gmail.com

Sponsor
Institute University of Toyama
Institute
Department

Funding Source
Organization University of Toyama
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
Email

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
2018 Year 11 Month 15 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 24 Day
Last modified on
2018 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039464

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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