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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013456
Receipt No. R000015663
Scientific Title Daily intake of Japanese apricot (Prunus mume Siebold et Zucc.; Ume) improves symptoms of upper gastrointestinal dysmotility associated with gastroesophageal reflux disease (GERD)
Date of disclosure of the study information 2014/03/19
Last modified on 2014/03/18

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Basic information
Public title Daily intake of Japanese apricot (Prunus mume Siebold et Zucc.; Ume) improves symptoms of upper gastrointestinal dysmotility associated with gastroesophageal reflux disease (GERD)
Acronym DaJapanese apricot (Ume) improves symptoms of upper gastrointestinal dysmotility associated with GERD
Scientific Title Daily intake of Japanese apricot (Prunus mume Siebold et Zucc.; Ume) improves symptoms of upper gastrointestinal dysmotility associated with gastroesophageal reflux disease (GERD)
Scientific Title:Acronym DaJapanese apricot (Ume) improves symptoms of upper gastrointestinal dysmotility associated with GERD
Region
Japan

Condition
Condition gastroesophageal reflux disease (GERD)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of Japanese Apricot on gastroesophageal reflux disease (GERD)-related symptoms.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes GERD-related symptoms were examined in Japanese individuals using the validated questionnaire, the Frequency Scale for Symptoms of GERD (FSSG)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
34 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria The participation people in the check-up program in Minabe-cho town.
Key exclusion criteria Subjects who have a previous history of surgical resection of gastrointestinal cancer, or H. pylori eradication , and those who have been prescribed a proton pump inhibitor or other digestive medicines are excluded. And those who do not reply to the FSSG questionnaire are excluded. In addition, subjects who regularly take processed JA, for example, JA extract, powdered JA or JA juice, other than dried and pickled JA, are excluded .
Target sample size 1400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Maekita
Organization School of Medicine, Wakayama Medical University
Division name Gastroenterology
Zip code
Address 811-1 Kimiidera, Wakayama City, Wakayama 641-0012, Japan
TEL 073-441-0627
Email maekita@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Maekita
Organization School of Medicine, Wakayama Medical University
Division name Gastroenterology
Zip code
Address 811-1 Kimiidera, Wakayama City, Wakayama 641-0012, Japan
TEL 073-441-0627
Homepage URL
Email maekita@wakayama-med.ac.jp

Sponsor
Institute Department of Health welfare, Minabe Town Office
Institute
Department

Funding Source
Organization Minabe Town Office
Organization
Division
Category of Funding Organization Local Government
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
2014 Year 03 Month 19 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 Enrolling by invitation
Date of protocol fixation
2010 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information GERD-related symptoms were examined in Japanese individuals using the validated questionnaire, 'the Frequency Scale for Symptoms of GERD (FSSG)', which is comprised of 7 questions associated with acid reflux symptoms and 5 questions asking about gastrointestinal dysmotility symptoms. FSSG scores are compared between subjects who taka one or more JA daily and those who do not.

Management information
Registered date
2014 Year 03 Month 18 Day
Last modified on
2014 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015663

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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