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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004710
Receipt No. R000005605
Scientific Title The evaluation of usefulness of peppermint oil solution as an antispasmodic drug for esophagogastroduodenoscopy.
Date of disclosure of the study information 2010/12/12
Last modified on 2010/12/12

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Basic information
Public title The evaluation of usefulness of peppermint oil solution as an antispasmodic drug for esophagogastroduodenoscopy.
Acronym The evaluation of usefulness of peppermint oil solution as an antispasmodic drug for esophagogastroduodenoscopy.
Scientific Title The evaluation of usefulness of peppermint oil solution as an antispasmodic drug for esophagogastroduodenoscopy.
Scientific Title:Acronym The evaluation of usefulness of peppermint oil solution as an antispasmodic drug for esophagogastroduodenoscopy.
Region
Japan

Condition
Condition esophagogastric disorder
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy and the usefulness of peppermint oil as an antispasmodic during upper endoscopy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The efficacy of antispasmodic scores was evaluated between the non-elderly patients and elderly patients
Key secondary outcomes safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A total of 8269 EGD procedures were carried out in Mitoyo General Hospital, Kagawa prefecture and Tsuyama Central Hospital, Okayama prefecture in Japan from March 2007 to September 2010. Peppermint oil was administered intraluminally during the procedure to 1893 patients (Group PO) with heart disease, prostate hypertrophy, and narrow angle glaucoma.
Peppermint oil solution is composed of peppermint oil (Yoshida Pharmaceutical Co.,Tokyo, Japan) distilled water by using the catalyst that is sorbitan monostearate (Wako Pure Chemical Industries, Osaka, Japan). About 20ml of 1.6% peppermint oil solution is administered directly to the antrum of the stomach at an initial stage of the procedure.
Interventions/Control_2 Hyoscine butylbromide (HB) (Buscopan®; Nippon Boehringer Ingelheim, Hyogo, Japan) was administered to the 6063 patients (Group HB)
Interventions/Control_3 Glucagon (GL) (Glucagon G Novo®; Novo Nordisk Pharma Ltd., Tokyo, Japan ) was administered to the 157 patients (Group GL)
Interventions/Control_4 156 patients (Group NO) carried out procedure without antispasmodic agents
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
13 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria The patients who are carried out EGD procedure
Key exclusion criteria Exclusion criteria were clinical evidence of severe diseases such as American Society of Anesthesiologists (ASA) classification of 4 or 5 at the time of procedure, peppermint allergy, and pregnancy or lactation.
Target sample size 8000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Imagawa
Organization Mitoyo General Hospital
Division name Department of Gastroenterology
Zip code
Address 708 Himehama Toyohama, Kan-onji-city, Kagawa, Japan
TEL 0875-52-3366
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Imagawa
Organization Mitoyo General Hospital
Division name Department of Gastroenterology
Zip code
Address 708 Himehama Toyohama, Kan-onji-city, Kagawa, Japan
TEL
Homepage URL
Email

Sponsor
Institute Endoscopy center in Mitoyo General Hospital
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
2010 Year 12 Month 12 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
Peppermint oil is efficacious and useful as an antispasmodic during EGD, especially in elderly patients.
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
2007 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 03 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
2010 Year 09 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 12 Day
Last modified on
2010 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005605

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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