UMIN-CTR Clinical Trial

Basic information
Public title	Effect of ninjin'yoeito on the skeletal muscle mass in gastric cancer patients: a multicenter randomized controlled trial
Acronym	Effect of ninjin'yoeito on the skeletal muscle mass in gastric cancer patients
Scientific Title	Effect of ninjin'yoeito on the skeletal muscle mass in gastric cancer patients: a multicenter randomized controlled trial
Scientific Title:Acronym	Effect of ninjin'yoeito on the skeletal muscle mass in gastric cancer patients
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of Ninjin'yoeito on skeletal muscle mass in gastric cancer patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Change of the ratio of skeletal muscle mass to body weight
Key secondary outcomes	(1) Change of body composition (2) Change of nutritional parameters (3) Adverse events and postoperative complications

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	No medication
Interventions/Control_2	Kracie Ninjin'yoeito Extract Granules, 7.5g per day
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) Histologically confirmed clinical stage I-III gastric cancer 2) At least one of the following symptoms: decreased strength after illness, fatigue/malaise, anorexia, night sweats, cold limbs or anemia 3) Age of 20 years or older 4) Eastern Cooperative Oncology Group performance status of 0-2 5) Sufficient oral intake 6) Written informed consent
Key exclusion criteria	1) Patients scheduled to preoperative chemotherapy and/or radiotherapy 2) Any Japanese herbal medicine within 4 weeks before the commencement of the study 3) Allergy to Japanese herbal medicine 4) Severe comorbidities, such as liver disease, renal disease, heart disease, lung disease, hematologic disease and metabolic disease 5) Electrolyte abnormalities 6) Cardiac pacemaker 7) Severe mental disorder 8) Pregnancy 9) Patient who is judged to be unsuitable for inclusion in the study by the investigators
Target sample size	52

Research contact person
Name of lead principal investigator	1st name Sohei Middle name Last name Matsumoto
Organization	Nara Medical University
Division name	Surgery
Zip code	634-8522
Address	840 Shijo-cho, Kashihara, Nara, 634-8522, Japan
TEL	0744-29-8863
Email	msohei@naramed-u.ac.jp

Public contact
Name of contact person	1st name Sohei Middle name Last name Matsumoto
Organization	Nara Medical University
Division name	Surgery
Zip code	634-8522
Address	840 Shijo-cho, Kashihara, Nara, 634-8522, Japan
TEL	0744-29-8863
Homepage URL
Email	msohei@naramed-u.ac.jp

Sponsor
Institute	Department of Surgery, Nara Medical University
Institute
Department

Funding Source
Organization	Department of Surgery, Nara Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee on Clinical Investigation of Nara Medical University
Address	840 Shijo-cho, Kashihara, Nara, Japan
Tel	0744-22-3051
Email	ino_rinri@naramed-u.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	奈良県立医科大学附属病院、奈良県西和医療センター、南奈良総合医療センター

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 01 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	Enrolling by invitation
Date of protocol fixation	2020 Year 04 Month 01 Day
Date of IRB	2020 Year 09 Month 02 Day
Anticipated trial start date	2020 Year 09 Month 18 Day
Last follow-up date	2023 Year 08 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	2020 Year 09 Month 18 Day
Last modified on	2020 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045397

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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