UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007686 |
|---|---|
| Receipt number | R000009065 |
| Scientific Title | Efficacy and safety of Rikkunshito for anorexia after total gastrectomy |
| Date of disclosure of the study information | 2012/04/09 |
| Last modified on | 2012/04/07 12:43:13 |
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Basic information
Public title
Efficacy and safety of Rikkunshito for anorexia after total gastrectomy
Acronym
Efficacy and safety of Rikkunshito for anorexia after total gastrectomy
Scientific Title
Efficacy and safety of Rikkunshito for anorexia after total gastrectomy
Scientific Title:Acronym
Efficacy and safety of Rikkunshito for anorexia after total gastrectomy
Region
| Japan |
Condition
Condition
after total gastrectomy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve the anorexia after total gastrectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Acyl ghrelin concentration in the blood
Key secondary outcomes
Gastrointestinal symptoms
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
Rikkunshito for 12 weeks
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who meet the following items of the patients who underwent total gastrectomy surgery
1 Older than six months after surgery
2 anorexia patients with 5cm or less in the VAS scale
3 Performance Status of 0 to 2 cases
4 Can be administered orally Rikkunshito
Key exclusion criteria
1 with a history of hypersensitivity to drug treatment
2 overlap with another cancer
3 taking other herbal preparations
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Nabeya |
Organization
Chiba university
Division name
Academic surgery
Zip code
Address
1-8-1, inohana, chuo-ku, chiba, chiba
TEL
043-226-2110
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Akai |
Organization
Chiba university
Division name
Academic surgery
Zip code
Address
1-8-1, inohana, chuo-ku, chiba, chiba
TEL
043-226-2110
Homepage URL
http://www.academic-surgery.jp/
akai@faculty.chiba-u.jp
Sponsor or person
Institute
Academic surgery of Chiba university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 09 | 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
| 2009 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 07 | Day |
Last modified on
| 2012 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009065
