UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041840 |
|---|---|
| Receipt number | 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 | 2022/01/27 10:55:28 |
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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
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
msohei@naramed-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Nara Medical University
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2022 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045397
