UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010873 |
|---|---|
| Receipt number | R000012724 |
| Scientific Title | The exploratory study for the efficacy and safety of rikkunshito on gastrointestinal symptoms in the patients who underwent gastrectomy |
| Date of disclosure of the study information | 2013/06/07 |
| Last modified on | 2021/08/17 14:08:11 |
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Basic information
Public title
The exploratory study for the efficacy and safety of rikkunshito on gastrointestinal symptoms in the patients who underwent gastrectomy
Acronym
The efficacy and safety of rikkunshito on gastrointestinal symptoms after gastrectomy
Scientific Title
The exploratory study for the efficacy and safety of rikkunshito on gastrointestinal symptoms in the patients who underwent gastrectomy
Scientific Title:Acronym
The efficacy and safety of rikkunshito on gastrointestinal symptoms after gastrectomy
Region
| Japan |
Condition
Condition
Gastric cancer patient who underwent gastrectomy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of rikkunshito on gastrointestinal symptoms in gastric cancer patients who underwent gastrectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) QOL score (ES3/EGQ, GSRS, SF-12)
2) body weight
3) body mass index
4) nutritional factor
(Alb, Pre-Alb, TP, T-Cho, WBC, Lym)
Key secondary outcomes
1)AST,ALT, GGTP,ALP,T-Bil, RBC, Hb, Hct, CRP, Na, K, creatinine, BUN
2)adverse events
3)side effects
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
Oral administration of rikkunshito
(2.5g t.i.d) before meals for 162 days
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who underwent LAPPG or LADG
2) Reconstructive surgery: no object
3) Staging of gastric cancer is IA (UICC TNM classification)
4) Patients with anorexia, early satiation, or postprandial fullness 7 days after surgery
5) Age: ≥ 20
6) Gender: no object
7) Outpatient or inpatient: no object
8) Agreement to sign an informed consent
Key exclusion criteria
1) Patients who have nutritional disorder before surgery
2) Patients who have another active malignancy
3) Patients with severe complications(ASA >=3 or PS>=2)
4) Patients with gastrointestinal bleeding, mechanical ileus, gastrointestinal perforation
5) Patients with mental disorder considered inappropriate by the study doctor
6) Patients with adjuvant chemotherapy after surgery
7) Patients receiving KAMPO medicine
8) Patients who has history of hypersensitivity to Kampo medicine
9) Patients who are pregnant, considering pregnancy or lactation
10) Patients considered inappropriate by the study investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Hiki |
Organization
The Cancer Institute Hospital of JFCR
Division name
Gastroenterological Surgery
Zip code
Address
3-8-31, Ariake, Koto, Tokyo
TEL
03-3520-0111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Hiki |
Organization
The Cancer Institute Hospital of JFCR
Division name
Gastroenterological Surgery
Zip code
Address
3-8-31, Ariake, Koto, Tokyo
TEL
03-3520-0111
Homepage URL
Sponsor or person
Institute
The Cancer Institute Hospital of JFCR
Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
TSUMURA & CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
がん研有明病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 07 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2014 | Year | 10 | 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
| 2013 | Year | 06 | Month | 04 | Day |
Last modified on
| 2021 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012724
