UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011469 |
|---|---|
| Receipt number | R000013400 |
| Scientific Title | Assessment of diminished peristalsis using shakuyakukanzoto as premedication for endoscopic retrograde cholangiopancreatography |
| Date of disclosure of the study information | 2013/11/30 |
| Last modified on | 2013/08/13 13:48:09 |
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Basic information
Public title
Assessment of diminished peristalsis using shakuyakukanzoto as premedication for endoscopic retrograde cholangiopancreatography
Acronym
Shakuyakukanzoto for ERCP
Scientific Title
Assessment of diminished peristalsis using shakuyakukanzoto as premedication for endoscopic retrograde cholangiopancreatography
Scientific Title:Acronym
Shakuyakukanzoto for ERCP
Region
| Japan |
Condition
Condition
Patients scheduled for ERCP at Toyama University Hospital
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Shakuyakukanzoto is a Kampo medicine, which is a part of traditionally practiced Japanese-based ancient Chinese medicine, reduces abdominal pain and muscular cramps quickly. Furthermore, it was reported that Shyakuyakukanzoto was suppressed the contractions of ileum. We reported that the inhibitory effect of Shakuyakukanzoto on duodenal peristalsis during ERCP at Japan Digestive Disease Week 2006, and Sakai et al. reported the confirmation of the suppressive effect of Shakuyakukanzoto on duodenal spasm during ERCP. These previous studies indicated that the inhibitory effect of Shyakuyakukanzoto on duodenal peristalsis. Our aim of this study is to the placebo-controlled trial to evaluate the clinical efficacy and safety of Shakuyakukanzoto as a premedication for ERCP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duodenal peristalsis stop rate after administration of Shyakuyakukanzoto
Key secondary outcomes
Measured a required time (RT) from administering premedication to diminished peristalsis and a peristalsis stop duration time (DT)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Shakuyakukanzoto solution was contained 5.0 g of Shakuyakukanzoto extract dissolved in 50 ml of warm water (36 degrees Celsius). As the premedication, the Shakuyakukanzoto solution was administered by spraying directly toward the major papilla of the duodenum through the endoscopy.
Interventions/Control_2
As a control, 50 ml of warm water (36 degrees Celsius) was prepared.
As the premedication, warm water (placebo ) was administered by spraying directly toward the major papilla of the duodenum through the endoscopy.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients need ERCP examination.
Key exclusion criteria
(1) Inability to provide written informed consent; (2) Inability to access duodenal papilla endoscopically; (3) Patients with ischemic heart disease, prostatic hypertrophy or glaucoma; (4) Patients with acute pancreatitis; (5) Serum K level >5.0 mEq/L
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Sugiyama |
Organization
University od Toyama
Division name
Department of Gastroenterology
Zip code
Address
2630 Sugitani, Toyama, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Toyama
Division name
Department of Gastroenterology
Zip code
Address
2630 Sugitani, Toyama
TEL
Homepage URL
Sponsor or person
Institute
University of Toyama, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 30 | 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
| 2006 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 05 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
| 2010 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2010 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 12 | Day |
Last modified on
| 2013 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013400
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| Registered date | File name |
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| Registered date | File name |
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