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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041840
Receipt No. R000045397
Scientific Title Effect of ninjin'yoeito on the skeletal muscle mass in gastric cancer patients: a multicenter randomized controlled trial
Date of disclosure of the study information 2020/10/01
Last modified on 2020/10/04

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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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