UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035873 |
|---|---|
| Receipt number | R000040869 |
| Scientific Title | Prospective study to elucidate physiology of Oketsu |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2022/08/16 12:01:39 |
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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
| Obstetrics 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
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
n-yoshikawa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University School of Medicine
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2019 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An in-hospital IRB application for this clinical trial was not filed.
Therefore, the approval date is tentative.
Management information
Registered date
| 2019 | Year | 02 | Month | 13 | Day |
Last modified on
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040869
