UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025992 |
|---|---|
| Receipt number | R000029758 |
| Scientific Title | A clinical study for evaluating the effects of P-chondroitin NHZ on knee joint symptoms |
| Date of disclosure of the study information | 2018/07/31 |
| Last modified on | 2019/02/06 19:41:34 |
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Basic information
Public title
A clinical study for evaluating the effects of P-chondroitin NHZ on knee joint symptoms
Acronym
Effects of P-chondroitin NHZ on knee joint symptoms
Scientific Title
A clinical study for evaluating the effects of P-chondroitin NHZ on knee joint symptoms
Scientific Title:Acronym
Effects of P-chondroitin NHZ on knee joint symptoms
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of P-chondroitin NHZ intake for 12 weeks on knee joint symptoms
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JKOM and VAS (pain, stiffness and discomfort of the knee)
Key secondary outcomes
JOA score
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
Intake of tablets containing P-chondroitin for 12 weeks
Interventions/Control_2
Intake of tablets that don't contain P-chondroitin (placebo) 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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subject, aged from 30 to 65 years males and females with pain of knee
2) Subject, be diagnosed KLgrade 0 or 1
3) Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent
Key exclusion criteria
1)Subjects having a medical history of rheumatism
2)Subjects who have leg pain or numbness
3)Subjects who have injury of semi-lunar disc or the other knee joint disease
4) Subjects receiving treatment for osteoarthritis
5) Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders
6) Subject presenting known allergy or history of pork
7) For female subject: pregnancy or breast feeding, or possibility of pregnancy, or intention to be pregnant during the study
8) Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months prior to the start of the present study
9) Subject who took part in another clinical trial within 3 months prior to the start of the present study or who is currently taking part in another clinical trial
10) Subject deemed unsuitable by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osami Kajimoto |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Medical Science on Fatigue
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-6171
kajimoto@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Sugino |
Organization
Soiken Inc.
Division name
Representative Director
Zip code
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi,Toyonaka,Osaka
TEL
06-6871-8888
Homepage URL
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
Funding Source
Organization
NH Foods Ltd. Research and Development Center
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
Address
Tel
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
医療法人弘正会ふくだ内科クリニック
Other administrative information
Date of disclosure of the study information
| 2018 | 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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 03 | Day |
Last modified on
| 2019 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029758
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
