UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011469
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute University of Toyama, Department of Gastroenterology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013400

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.