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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037556
Receipt No. 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

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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
Email 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
Email kosehira@omnica.co.jp

Sponsor
Institute IMEQRD Co., Ltd
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042471

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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