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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038290
Receipt No. 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

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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
Email 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
Email m-sakashita@pharmafoods.co.jp

Sponsor
Institute Pharma Foods International Co., Ltd.
Institute
Department

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 -
Email -

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043645

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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