UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038859 |
|---|---|
| Receipt number | 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 | 2020/12/11 16:37:23 |
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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
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
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 05 | Day |
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
| 2020 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044315
