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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038859
Receipt No. R000044315
Scientific Title A randomized, double-blind, placebo- controlled, parallel-group study on the effect of N-acetylglucosamine on discomfort in the knee.
Date of disclosure of the study information 2019/12/15
Last modified on 2019/12/12

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Basic information
Public title A randomized, double-blind, placebo-
controlled, parallel-group study on the effect of N-acetylglucosamine on discomfort in the knee.
Acronym Effect of N-acetylglucosamine on discomfort in the knee.
Scientific Title A randomized, double-blind, placebo-
controlled, parallel-group study on the effect of N-acetylglucosamine on discomfort in the knee.
Scientific Title:Acronym Effect of N-acetylglucosamine on discomfort in the knee.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of N-acetylglucosamine ingestion for 12 weeks on discomfort in the knee.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes JOA Score
Key secondary outcomes JKOM Scor, Knee joint subjective symptoms (VAS), KS Score, J-KOOS
Interview, Body weight, Blood pressure, Pulse rate, Subjective and objective symptoms, Adverse events, Hematologic test, Blood biochemistry test, Urine analysis

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 YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of supplement containing N-acetylglucosamine for 12 weeks.
Interventions/Control_2 Ingestion of placebo without N-acetylglucosamine 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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Healthy males and females aged 20 to 69 years old
2. Subjects who experience discomfort or pain in the knee and are classified into 0-I grade based on the Kellgren-Lawrence classification
3. Individuals who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria 1. Individuals who are under treatment, have a history, or are suspected to have rheumatoid arthritis
2. Individuals who need treatment and medication for osteoarthritis
3. Individuals with history of surgical therapy (artificial joint) on knees.
4. Individuals who continuously use compress, topical cream, and/or analgesic agent etc. on knee region
5. Individuals who have injury of semi-lunar disc or the other knee joint disease
6. Individuals who are under treatment of serious chronic diseases e.g., liver disease, heart and/or vascular disease, respiratory disorder, endocrine disorder, or metabolic diseases
7. Individuals who cannot stop using supplements and/or functional foods affecting knee cartilage
8. Individuals who have a history of food allergy
9. Individuals who hope for pregnancy in the test duration, pregnant women, lactating women
10. Individuals who are planning to participate or already participating in other clinical studies
11. Individuals who are judged as unsuitable for the study by the investigator for other reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yasuo
Middle name
Last name Kobuna
Organization Kobuna Orthopedics Clinic
Division name Director
Zip code 371-0813
Address 311-2 Gokan-machi, Maebashi-shi, Gumma 371-0813, Japan
TEL 027-261-7600
Email info@kobunaseikei.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code 105-0023
Address 1-9-7 Shibaura, Minato-ku, Tokyo 105-0023, Japan
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Yaizu Suisankagaku Industry 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 Ethical Committee of Kobuna Orthopedics Clinic
Address 5-656-17 Joutou-machi, Maebashi-shi, Gunma, Japan
Tel 027-212-5608
Email sagawa@mc-connect.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
2019 Year 12 Month 15 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 12 Month 04 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 16 Day
Last follow-up date
2020 Year 04 Month 18 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 12 Month 12 Day
Last modified on
2019 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044315

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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