UMIN-CTR Clinical Trial

Public title

The efficacy evaluation of Saccharomyces cerevisiae SM-10 on the joints

Acronym

Efficacy evaluation of Saccharomyces cerevisiae SM-10 on the joints

Scientific Title

The efficacy evaluation of Saccharomyces cerevisiae SM-10 on the joints

Scientific Title:Acronym

Efficacy evaluation of Saccharomyces cerevisiae SM-10 on the joints

Region

Japan

Condition

Healthy adult

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of SM-10 supplements on the functions of movement, cartilage metabolism and liver

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Levels of change in locomotive syndrome risk test at 6 and 12 weeks.

Key secondary outcomes

Levels of change in JKOM, JHEQ, JLEQ, JOA, VAS (knee pain), COMP, liver function (AST, ALT, gamma-GTP).
Levels of change in knee joint stiffness.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

SM-10 supplements are ingested for 12 consecutive weeks at 600 mg.

Interventions/Control_2

Placebo are ingested for 12 consecutive.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

45

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Males and females at the ages of 45 to 64
2. Subjects who confirmed pain of knee joint by JKOM and VAS.
3. Subjects who are judged as stage 1 in locomotive syndrome risk test
4. Subjects who are classified into 0-I grade on the basis of the Kellgren-Lawrence classification. (Subjects who undiagnosed with Knee Osteoarthritis by physician)

Key exclusion criteria

1. Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability
2. Subjects who are suspected gouty attack with hyperuricemia
3. Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain
4. Subjects who have performed arthroplasty or need it
5. Subjects who regularly take health food containing bone, joint, muscle wellness from three month before the screening test to the end of the study
6. Subjects who regularly take medicine
7. Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test
8. Subjects who get an intense exercise to make excessive load on the joints
9. Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test
10. Subjects who regularly use a stick or supporter
11. Subjects who routinely exert an influence on the efficacy evaluation
12. Subjects who get a diagnosis of malignancy, are under treatment for hypertension, cardiac disease, renal disease and thyroid dysfunction, and have a history of serious disorder such as hepatic disease
13. Subjects who consume an excess amounts of alcohol
14. Subjects who have possibility of allergy symptoms onset by the test supplement
15. Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
16. Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period
17. Subjects who intend to become pregnant or lactating
18. Subjects who are judged as unsuitable for this study by physician

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	hiroyuki kimura

Organization

Horus Co., Ltd.

Division name

Academic Planning Department

Zip code

Address

3-3-5 Nakano Nakano-ku Tokyo

TEL

03-5328-9331

Email

kimura.hiroyuki@horus-jnl.co.jp

Name of contact person

1st name
Middle name
Last name	Sayuri Fujita

Organization

Horus Co., Ltd.

Division name

Academic Planning Department

Zip code

Address

3-3-5 Nakano Nakano-ku Tokyo

TEL

03-5328-9331

Homepage URL

http://horus-jnl.com/

Email

gakujutu.mail@horus-jnl.co.jp

Institute

TTC CO., LTD.

Institute

Department

Personal name

Organization

Horus Co., Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

06

Month

14

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Jpn Pharmacol Ther 2017, 45 (6), 1031-44

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

Recruitment status

Main results already published

Date of protocol fixation

2016

Year

05

Month

26

Day

Date of IRB

Anticipated trial start date

2016

Year

06

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

06

Month

14

Day

Last modified on

2017

Year

08

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026198