UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062555 |
|---|---|
| Receipt number | R000070817 |
| Scientific Title | Exploratory Efficacy and Safety of a Genistein-Containing Nutritional Supplement for Finger Symptoms in Middle-Aged Women: A Randomized Double-Blind Placebo-Controlled Trial |
| Date of disclosure of the study information | 2026/08/13 |
| Last modified on | 2026/08/12 13:14:54 |
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Basic information
Public title
Randomized Double-Blind Trial of a Genistein-Containing Nutritional Supplement for Finger Symptoms in Middle-Aged Women
Acronym
Genistein Supplement Trial for Finger Symptoms
Scientific Title
Exploratory Efficacy and Safety of a Genistein-Containing Nutritional Supplement for Finger Symptoms in Middle-Aged Women: A Randomized Double-Blind Placebo-Controlled Trial
Scientific Title:Acronym
Genistein Finger Symptom Trial
Region
| Japan |
Condition
Condition
Finger symptoms in middle-aged women
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the exploratory efficacy and safety of a genistein-containing nutritional supplement for finger symptoms, including pain, stiffness, and numbness, in middle-aged women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline to Week 24 in finger pain visual analog scale (VAS) score.
Key secondary outcomes
Change from baseline to Week 24 in finger stiffness VAS score
Change from baseline to Week 24 in finger numbness VAS score
QuickDASH-JSSH disability/symptom score
QuickDASH work module score
QuickDASH sports/arts module score
Adherence rate
Adverse events
Body weight, BMI, blood pressure, and pulse rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants receive a genistein-containing nutritional supplement for 24 weeks. The study product is taken daily according to the specified administration schedule and prescribed daily dose.
Interventions/Control_2
Participants receive a matching placebo without the active ingredient for 24 weeks. The placebo is taken daily according to the same administration schedule and prescribed daily dose as the active supplement.
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
Women aged 40 to less than 65 years
Participants with self-reported finger pain, stiffness, and/or numbness
Participants who provide written informed consent
Participants who are able to continuously take the assigned study product or placebo during the study period
Key exclusion criteria
Participants with known allergy to soy-derived products
Participants with severe systemic disease judged inappropriate for study participation by the investigators
Participants currently participating in another clinical trial
Participants who are pregnant, breastfeeding, or may become pregnant
Participants otherwise judged unsuitable for study participation by the investigators
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Toshikazu |
| Middle name | |
| Last name | Tanaka |
Organization
Medical Corporation Yorisoute Kashiwa Hand Clinic
Division name
Director
Zip code
277-0005
Address
Kashiwa Higashiguchi Kaneko Bldg. 3F, 4-8-1 Kashiwa, Kashiwa-shi, Chiba 277-0005, Japan
TEL
04-7164-2825
tanaka1041@msn.com
Public contact
Name of contact person
| 1st name | Toshikazu |
| Middle name | |
| Last name | Tanaka |
Organization
Medical Corporation Yorisoute Kashiwa Hand Clinic
Division name
Director
Zip code
277-0005
Address
Kashiwa Higashiguchi Kaneko Bldg. 3F, 4-8-1 Kashiwa, Kashiwa-shi, Chiba 277-0005, Japan
TEL
04-7164-2825
Homepage URL
https://www.kashiwa-hand.com/
tanaka1041@msn.com
Sponsor or person
Institute
Kikkoman NutriCare Japan Co., Ltd.
Institute
Department
Personal name
Toru Izumi
Funding Source
Organization
Kikkoman NutriCare Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
CPCC Co., Ltd.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Chiyoda Paramedical Care Clinic Ethics Committee
Address
Daiwa Building 2F, 3-3-10 Nihonbashi Hongokucho, Chuo-ku, Tokyo, Japan
Tel
03-6225-9005
privacy@cpcc.co.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
医療社団法人よりそう手 柏 Hand クリニック（千葉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.kashiwa-hand.com/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
25
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
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 10 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 17 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 11 | Day |
Last modified on
| 2026 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070817
