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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035873
Receipt No. R000040869
Scientific Title Prospective study to elucidate physiology of Oketsu
Date of disclosure of the study information 2019/10/01
Last modified on 2020/02/18

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Basic information
Public title Prospective study to elucidate physiology of Oketsu
Acronym Prospective study to elucidate physiology of Oketsu
Scientific Title Prospective study to elucidate physiology of Oketsu
Scientific Title:Acronym Prospective study to elucidate physiology of Oketsu
Region
Japan

Condition
Condition Oketsu with lower abdominal pain
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 In this research, we plan to enroll a wide range of women from healthy people to Oketsu women and analyze lifestyle habits, symptoms, body findings, and multi-omics data of biological samples in an integrated manner. It is aimed to identify diagnostic markers and the genetic background and lifestyle that become the cause of Oketsu.
Basic objectives2 Others
Basic objectives -Others Elucidate the mechanism of Oketsu
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Lifestyle (diet, defecation, urination, exercise etc)
Symptoms (cold, pain etc)
Blood sampling data
Omics data
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) Patients with chief complaint of symptoms of Oketsu such as spots, shoulder stiffness, chilliness, back pain, frozen shoulder, headache, stomachache, lower abdominal discomfort, lower abdominal pain, menstrual pain, annoyance, dizziness, nausea and other symptoms
2) Patients with ECOG-PS 0 or 1
Key exclusion criteria Nothing particular
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Kajiyama
Organization Nagoya University School of Medicine
Division name Department of obstetrics and gynecology
Zip code 4668550
Address Tsuruma-cho 65, Showa-ku, Nagoya
TEL 052-744-2261
Email kajiyama@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Nobuhisa
Middle name
Last name Yoshikawa
Organization Nagoya University School of Medicine
Division name Department of obstetrics and gynecology
Zip code 4668550
Address Tsuruma-cho 65, Showa-ku, Nagoya
TEL 052-744-2261
Homepage URL
Email n-yoshikawa@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University School of Medicine
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 IRB
Address Tsuruma-cho 65, Showa-ku, Nagoya
Tel 052-744-2423
Email iga-shinsa@adm.nagoya-u.ac.jp

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
2019 Year 10 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2020 Year 02 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Lifestyle (diet, defecation, urination, exercise etc)
Symptoms (cold, pain etc)
Blood sampling data
Omics data

Management information
Registered date
2019 Year 02 Month 13 Day
Last modified on
2020 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040869

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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