UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037556 |
|---|---|
| Receipt number | R000042471 |
| Scientific Title | Investigation of the effects of 8-week continuous ingestion of plant tuber extract on knee joint: a double-blind, randomized and parallel study |
| Date of disclosure of the study information | 2019/07/31 |
| Last modified on | 2019/07/29 17:24:48 |
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Basic information
Public title
Investigation of the effects of 8-week continuous ingestion of plant tuber extract on knee joint: a double-blind, randomized and parallel study
Acronym
Investigation of the effects of 8-week continuous ingestion of plant tuber extract on knee joint: a double-blind, randomized and parallel study
Scientific Title
Investigation of the effects of 8-week continuous ingestion of plant tuber extract on knee joint: a double-blind, randomized and parallel study
Scientific Title:Acronym
Investigation of the effects of 8-week continuous ingestion of plant tuber extract on knee joint: a double-blind, randomized and parallel study
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the test food to knee joint and QOL in men and women aged 40 or over to under 75 who feel discomfort in the knee joints of either or both feet.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese Knee Osteoarthritis Measure (JKOM)
Key secondary outcomes
Questionnaire
The 25-question geriatric locomotive function scale
Assess high sensitivity C-reactive protein
Hematologic test, Blood biochemical test
Urine analysis
Adverse events
Number of occurrences of side effects
Height, weight, BMI, blood pressure, pulse rate
Other associated symptoms
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
plant tuber extract 210 mg, 8weeks
Interventions/Control_2
Placebo, 8weeks
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects who aged more than 40 years, less than 75 years. (at the time of submission of an informed consent)
2) Healthy subjects (who were judged as healthy individuals by the principal investigator)
3) Men and women
4) Subjects who have a discomfort in the knee joints of both feet or one foot.
5) Subjects whose question I in the JKOM questionnaire is more than 20 mm.
6) Subjects who can use smartphone.(who can use electronic diaries)
7) Subjects who do not intend to change or do not change everyday lifestyle habits during the study period.
8) Subjects who can continue to take test food for 8 weeks.
9) Subjects who can provide their written informed consent.
Key exclusion criteria
1) Currently in treatment with medical products.
2) Currently under exercise and diet treatment.
3) Currently visiting hospital for treatment of knee pain.
4) More than 2 of KL (Kellgren-Lawrence) classification grade.
5) Diagnosed with hyperuricemia and the possible occurrence of an attack of gout.
6) Diagnosed with severe disorders such as diabetes, a circulatory disease, a hepatic disease, a renal disease and a cardiac disease, or previous history.
7) Positive at rheumatoid factor, or may cause pain from rheumatism.
8) Undergone or need knee surgery.
9) Need for pharmacological articular treatments during the study.
10) Undergone a hyaluronic acid injection within two weeks before the selection or a steroid injection within three months before the selection.
11) Diagnosed with bone or joint-related diseases such as a fracture and a sprain within the past three months.
12) Regular intake of health food that contains hyaluronic acid, glucosamine, chondroitin sulfuric acid, quercetin glycoside, vitamin D, or an amino-acid drug, or have the intention of consuming the health food during the study.
13) Regular intake of a medical products with an influence on the evaluation of the study (particularly, a medical products that contains glucosamine, chondroitin sulfuric acid, vitamin D or an amino-acid drug, or a medical products for the treatment of osteoporosis).
14) Excessive alcohol (over 60 g per day) intake.
15) Regular use of a cane.
16) Medical history of drug or food allergy.
17) Having the potential to become pregnant during the study or currently pregnant (including a possibility of being pregnant) or nursing.
18) Currently or history of drug abuse.
19) More than 30 kg / m2 of BMI.
20) Participated in other clinical trials within a month from the date of obtaining consent, or during the study.
21) Matched with exclusion criteria, since submission of an informed consent.
22) Unsuitable for enrollment in the opinion of the principal or sub investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Marie |
| Middle name | |
| Last name | Kosehira |
Organization
Omnica Co.,Ltd
Division name
Research Dept.
Zip code
1120002
Address
TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5840-9815
kosehira@omnica.co.jp
Public contact
Name of contact person
| 1st name | Marie |
| Middle name | |
| Last name | Kosehira |
Organization
Omnica Co.,Ltd
Division name
Research Dept.
Zip code
1120002
Address
TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5840-9815
Homepage URL
kosehira@omnica.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Omnica 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6205-6222
suda-clinic_irb@imeq.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
医療法人社団浩央会 東小金井さくらクリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | 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
| 2019 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 06 | 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 | 07 | Month | 31 | Day |
Last modified on
| 2019 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042471
