UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038290 |
|---|---|
| Receipt number | R000043645 |
| Scientific Title | Effects of food ingredients on knee joint symptoms in healthy volunteers with knee joint symptoms. |
| Date of disclosure of the study information | 2019/10/14 |
| Last modified on | 2020/04/22 16:47:58 |
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Basic information
Public title
Effects of food ingredients on knee joint symptoms in healthy volunteers with knee joint symptoms.
Acronym
Effects of food ingredients on knee joint symptoms.
Scientific Title
Effects of food ingredients on knee joint symptoms in healthy volunteers with knee joint symptoms.
Scientific Title:Acronym
Effects of food ingredients on knee joint symptoms.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of ingestion of food ingredients on knee joint subjective symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JKOM, JOA
Key secondary outcomes
Knee joint subjective symptoms (VAS)
Blood test (CTx-II, C2C, PIIANP)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of food ingredients-1 for 12 consecutive weeks.
Interventions/Control_2
Ingestion of food ingredients-2 for 12 consecutive weeks.
Interventions/Control_3
Ingestion of food ingredients-3 for 12 consecutive weeks.
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
Male and Female
Key inclusion criteria
1. Subjects who are adult male and female with subjective symptoms of knee joint pain.
2. Subjects with relatively high degree of knee pain in subjective symptoms.
3. Subjects who have agreed to participate in this study.
Key exclusion criteria
1. Subjects with a history of treatment of malignant tumor, heart failure, myocardial infarction.
2. Subjects receiving treatment for the following chronic diseases, atrial fibrillation, arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, knee joint disease, other chronic diseases.
3. Subjects who routinely use medicines (including herbal medicine).
4. Subjects who are taking action to improve knee joint pain (including going to the hospital and treatment), and using medicines and health foods.
5. Subjects with allergies (medicine / test food related food).
6. Subjects who are planning to become pregnant or lactating.
7. Subjects who are judged as unsuitable for the study by doctor for other reasons.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Yamatsu |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development Department
Zip code
615-8245
Address
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
TEL
075-394-8605
a-yamatsu@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | Maya |
| Middle name | |
| Last name | Sakashita |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development Department
Zip code
615-8245
Address
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
TEL
075-394-8605
Homepage URL
m-sakashita@pharmafoods.co.jp
Sponsor or person
Institute
Pharma Foods International Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Pharma Foods International Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
-
Address
-
Tel
-
-
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 | 14 | 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
48
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 04 | 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
| 2019 | Year | 10 | Month | 14 | Day |
Last modified on
| 2020 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043645
