UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039588 |
|---|---|
| Receipt number | R000045145 |
| Scientific Title | The effect of functional food X on the symptoms of finger joint in healthy postmenopausal women -Randomized, double-blind, placebo-controlled parallel-group comparative study- |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2020/02/25 11:39:35 |
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Basic information
Public title
The effect of functional food X on the symptoms of finger joint in postmenopausal women
Acronym
The effect of functional food X on the symptoms of finger joint
Scientific Title
The effect of functional food X on the symptoms of finger joint in healthy postmenopausal women
-Randomized, double-blind, placebo-controlled parallel-group comparative study-
Scientific Title:Acronym
The effect of functional food X on the symptoms of finger joint in healthy postmenopausal women
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We confirm the effect of functional food X on the symptoms of finger joint for 12 weeks compared to placebo food in healthy postmenopausal women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change percentage of visual analog scale from baseline at 12 weeks
Key secondary outcomes
-The changes in VAS, scores and number of joints of fingers with pain and discomfort from baseline to 4, 8, and 12 weeks
-The Changes in finger condition and physical condition from baseline at 12 weeks
-Adverse events and side effects that occurred between the start of ingestion and the end of the post-observation period or at the time of discontinuation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Twice per day, for 12 weeks
Interventions/Control_2
Twice per day, for 12 weeks
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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
-Postmenopausal women
-Individuals who have the symptoms of finger joint that do not require treatment
Key exclusion criteria
-Individuals who are under medical treatment
-Individuals who receiving hormone replacement treatment or using Chinese medicine for menopausal symptoms within the past six months
-Individuals who regularly use painkillers
-Individuals who have history of rheumatoid arthritis and other collagen diseases
-Individuals who are allergic to food or medicine
-Individuals who are diagnosed as inappropriate for the trial by the principal Investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Ueno-Asagao Clinic
Division name
Hea
Zip code
110-0015
Address
2-7-5, Higashiueno, Taito-ku, Tokyo
TEL
03-6240-1162
jimukyoku@tes-h.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings CO., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
2-7-5, Higashiueno, Taito-ku, Tokyo
TEL
03-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings CO., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
2-7-5, Higashiueno, Taito-ku, Tokyo
Tel
03-6240-1162
jimukyoku@tes-h.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 31 | 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
| 2020 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 25 | Day |
Last modified on
| 2020 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045145
