UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060813 |
|---|---|
| Receipt number | R000069582 |
| Scientific Title | Research on the Effects of Genistein-Containing Intake on Menopausal Hand |
| Date of disclosure of the study information | 2026/03/03 |
| Last modified on | 2026/03/03 22:58:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on the Effects of Genistein-Containing Intake on Menopausal Hand
Acronym
Effects of Genistein Intake on Menopausal Hand
Scientific Title
Research on the Effects of Genistein-Containing Intake on Menopausal Hand
Scientific Title:Acronym
Effects of Genistein Intake on Menopausal Hand
Region
| Japan |
Condition
Condition
Research on the Effects of Genistein-Containing Intake on Menopausal Hand
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of genistein intake on menopausal hand.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The aim of this study is to investigate the effects of genistein intake on menopausal hand.
Primary outcome measures, Changes in menopausal hand symptoms, including morning stiffness, finger pain, and numbness are evaluated using patient-reported outcome measures, VAS, DASH, FIHOA, and Hand20.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants are instructed to take one capsule daily of a functional food containing 13.5 mg of genistein for three months, and changes in menopausal hand symptoms are evaluated.
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Individuals capable of consuming genistein-containing functional foods daily for three months.
Individuals capable of attending outpatient visits one month, two months, and three months after consuming the functional food.
Individuals who, after receiving sufficient explanation regarding participation in this study, provided written consent based on full understanding and their own free will.
Individuals who received explanations about both the equol-containing functional food and the genistein-containing functional food and expressed a desire to consume the genistein-containing functional food.
Key exclusion criteria
Individuals wishing to consume other functional foods containing soy isoflavones.
Individuals with abnormal liver or kidney function detected in pre-study blood tests.
Other individuals deemed unsuitable as study subjects by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | TOMOYO |
| Middle name | |
| Last name | IRIE |
Organization
Hokkaido University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
060-8638
Address
7-chome, Kita 15-jo, Kita Ward, Sapporo City, Hokkaido
TEL
0117161161
seikeigeka-ikyoku@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | TOMOYO |
| Middle name | |
| Last name | IRIE |
Organization
Hokkaido University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
060-8638
Address
7-chome, Kita 15-jo, Kita Ward, Sapporo City, Hokkaido
TEL
0117161161
Homepage URL
seikeigeka-ikyoku@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
non
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
Department of Orthopaedic Surgery, Hokkaido University
Address
7-chome, Kita 15-jo, Kita Ward, Sapporo City, Hokkaido
Tel
011-716-1161
seikeigeka-ikyoku@pop.med.hokudai.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
| 2026 | Year | 03 | Month | 03 | 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
| 2026 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 03 | Day |
Last modified on
| 2026 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069582
