UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048625
Receipt number R000055400
Scientific Title Clinical trials on the efficacy and safety of Shikuwasa seed extract for motor function
Date of disclosure of the study information 2022/08/08
Last modified on 2022/12/26 14:42:18

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Basic information

Public title

Clinical trials on the efficacy and safety of Shikuwasa seed extract extracted from Shikuwasa seed for motor function

Acronym

Clinical trials on the efficacy and safety of Shikuwasa seed extract for motor function

Scientific Title

Clinical trials on the efficacy and safety of Shikuwasa seed extract for motor function

Scientific Title:Acronym

Clinical trials on the efficacy and safety of Shikuwasa seed extract for motor function

Region

Japan


Condition

Condition

Decline in motor function with aging

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verification of the safety and efficacy of Shikuwasa seed extract for motor function and anti-obesity

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

6-minute walking test

Key secondary outcomes

BMI, body fat percentage, grip strength measurement, chair standing test, HbA1c


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

The test product is No. 2 hard capsule (made of hydroxypropyl methylcellulose) containing 160 mg of Shikuwasa seed extract (containing 65% nomilin and 25% limonin).
The 50 subjects will be divided into a test product group (25 patients) and a placebo group (25 patients), and the distribution will be randomized and double-blind. Ingestion is 2 capsules once daily for 12 weeks in the morning.

Interventions/Control_2

placebo is No. 2 hard capsule containing dextrin.

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

65 years-old <=

Age-upper limit

90 years-old >=

Gender

Female

Key inclusion criteria

Women over the age of 65 who are basically healthy but feel some decline in motor function with age.

Key exclusion criteria

1.Those who are being treated for motor dysfunction or taking supplements thereof
2.Those within half a year after the end of treatment for motor dysfunction
3.Those with disabilities in the limbs
4.Those who need long-term care to stand up or walk
5.Things that are difficult to communicate
6.Others that the attending physician deems inappropriate for registration in this study

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Kimio
Middle name
Last name Sugaya

Organization

Southern Nights' Laboratory Co., Ltd.

Division name

CEO

Zip code

904-0113

Address

1-1-823 Miyagi, Chatan, Okinawa

TEL

09049987459

Email

sugaya@sklabo.co.jp


Public contact

Name of contact person

1st name Kimio
Middle name
Last name Sugaya

Organization

Southern Knights' Laboratory Co., Ltd.

Division name

CEO

Zip code

904-0113

Address

1-1-823 Miyagi, Chatan, Okinawa

TEL

09049987459

Homepage URL


Email

sugaya@sklabo.co.jp


Sponsor or person

Institute

Southern Nights' Laboratory Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Okinawa Prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor

NatuPharma Ryukyus, Co., Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kawahara Urology Ethics Review Board

Address

73-3 Nishimotida, Aira, Kagoshima

Tel

0995-64-5181

Email

yamashita.hami@kawahara.or.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

2022 Year 08 Month 08 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

2022 Year 07 Month 06 Day

Date of IRB

2022 Year 07 Month 27 Day

Anticipated trial start date

2022 Year 08 Month 21 Day

Last follow-up date

2022 Year 12 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 08 Month 08 Day

Last modified on

2022 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055400


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name