UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013456 |
|---|---|
| Receipt number | 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 17:10:27 |
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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
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
maekita@wakayama-med.ac.jp
Sponsor or person
Institute
Department of Health welfare, Minabe Town Office
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015663
