UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038289
Receipt number R000043644
Scientific Title Effects of supplements on knee joint symptoms in healthy volunteers with knee joint symptoms.
Date of disclosure of the study information 2019/10/14
Last modified on 2020/04/22 16:30:00

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Basic information

Public title

Effects of supplements on knee joint symptoms in healthy volunteers with knee joint symptoms.

Acronym

Effects of supplements on knee joint symptoms.

Scientific Title

Effects of supplements on knee joint symptoms in healthy volunteers with knee joint symptoms.

Scientific Title:Acronym

Effects of supplements on knee joint symptoms.

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to evaluate the effects of ingestion of supplements on knee joint subjective symptoms.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

JKOM, JOA

Key secondary outcomes

Knee joint subjective symptoms (VAS)
Blood test (CTx-II, C2C, PIIANP)


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

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of supplement-1 for 12 consecutive weeks.

Interventions/Control_2

Ingestion of supplement-2 for 12 consecutive weeks.

Interventions/Control_3

Ingestion of placebo for 12 consecutive weeks.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Subjects who are adult male and female with subjective symptoms of knee joint pain.
2. Subjects who are classified into 0-I grade on the basis of the Kellgren-Lawrence classification (Subjects who undiagnosed with knee osteoarthritis by doctor).
3. Subjects who have agreed to participate in this study.

Key exclusion criteria

1. Subjects with a history of treatment of malignant tumor, heart failure, myocardial infarction.
2. Subjects receiving treatment for the following chronic diseases, atrial fibrillation, arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, knee joint disease, other chronic diseases.
3. Subjects who routinely use medicines (including herbal medicine).
4. Subjects who are taking action to improve knee joint pain (including going to the hospital and treatment), and using medicines and health foods.
5. Subjects with allergies (medicine / test food related food).
6. Subjects who are planning to become pregnant or lactating.
7. Subjects who are judged as unsuitable for the study by doctor for other reasons.

Target sample size

48


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Yamatsu

Organization

Pharma Foods International Co., Ltd.

Division name

Research and Development Department

Zip code

615-8245

Address

1-49 Goryo-Ohara, Nishikyo-ku, Kyoto

TEL

075-394-8605

Email

a-yamatsu@pharmafoods.co.jp


Public contact

Name of contact person

1st name Maya
Middle name
Last name Sakashita

Organization

Pharma Foods International Co., Ltd.

Division name

Research and Development Department

Zip code

615-8245

Address

1-49 Goryo-Ohara, Nishikyo-ku, Kyoto

TEL

075-394-8605

Homepage URL


Email

m-sakashita@pharmafoods.co.jp


Sponsor or person

Institute

Pharma Foods International Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Pharma Foods International 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

-

Address

-

Tel

-

Email

-


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 10 Month 14 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

34

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

No longer recruiting

Date of protocol fixation

2019 Year 06 Month 27 Day

Date of IRB

2019 Year 07 Month 17 Day

Anticipated trial start date

2020 Year 01 Month 15 Day

Last follow-up date

2020 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Intervention 2 was not conducted because the target number of participants was not reached.


Management information

Registered date

2019 Year 10 Month 14 Day

Last modified on

2020 Year 04 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043644


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name