UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015911
Receipt number R000018519
Scientific Title The test of the improvement effect for knee joint of the S-adenosylmethionine-containing food
Date of disclosure of the study information 2014/12/10
Last modified on 2015/02/20 10:05:24

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Basic information

Public title

The test of the improvement effect for knee joint of the S-adenosylmethionine-containing food

Acronym

The test of the improvement effect for knee joint of the S-adenosylmethionine-containing food

Scientific Title

The test of the improvement effect for knee joint of the S-adenosylmethionine-containing food

Scientific Title:Acronym

The test of the improvement effect for knee joint of the S-adenosylmethionine-containing food

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of the product containing S-adenosyl methionine (SAMe) yeast on knee joint

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Questionnaires(VAS, bodily sensation)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

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

SAMe yeast(4weeks)

Interventions/Control_2

Placebo (4weeks)

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

35 years-old <=

Age-upper limit

59 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Healthy males and females aged 35 to 59 years old
(2)Subjects who feel discomfort on knee joint since over 3 months ago, and the discomfort are still continuing

Key exclusion criteria

(1)Patients under medical treatment
(2)Subjects who have previous medical history of drug and/or food allergy
(3)Subjects who have hypertension (not less than level 3)
(4)Subjects who have previous medical history of the serious diseases (heart, liver, kidney, blood, digestive system,metabolism system)
(5)Patients being treated for rheumatoid arthritis
(6)Subjects who have disturbance of motility
(7)Subjects who use SAMe-containing-foods and/or functional foods that have mitigation or treatment effect for joint pain (e.g., amino acid, protein, vitamin D, chondroitin, collagen, and/or glucosamine), and can't stop using during this trial
(8)Subjects who take medicines and plan to take new health foods
(9)Subjects who hope for pregnancy in the test duration, pregnant woman, lactating woman
(10)Subjects who have been enrolled in the other clinical trials within about last 1 month
(11)Subjects whose declaration of application is incorrect clearly
(12)Subjects who are judged as unsuitable for the trial by the investigator or subinvestigator for other reasons

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruo MARUYAMA

Organization

Universal Clinical Systems Co., Ltd.

Division name

Clinical Research Planning Department

Zip code


Address

4F Komori Build. 2-5-3 Kyobashi Chuo-ku, Tokyo Japan

TEL

03-3816-3121

Email

info@uc-system.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriko YAMANAKA

Organization

Omnica Co.,Ltd

Division name

Research team

Zip code


Address

TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN

TEL

03-5840-9811

Homepage URL


Email

yamanaka@omnica.co.jp


Sponsor or person

Institute

Universal Clinical Systems Co., Ltd.

Institute

Department

Personal name



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


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

2014 Year 12 Month 10 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

2014 Year 12 Month 09 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 11 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

2014 Year 12 Month 10 Day

Last modified on

2015 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018519


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name