UMIN-CTR Clinical Trial

Public title

Evaluation of the anti-stress effect of rosemary materials

Acronym

Evaluation of the anti-stress effect of rosemary materials

Scientific Title

A randomized, placebo-controlled, double-blind, three-dose, crossover study

Scientific Title:Acronym

A randomized, placebo-controlled, double-blind, three-dose, crossover study

Region

Japan

Condition

healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To confirm the presence or absence of anti-stress effect of rosemary extract and to determine the effective intake amount.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1.Health concept assessment (health-related QOL measurement)
2.Uchida-Kreperin test index (work efficiency, percentage of correct answers)
3.Salivary amylase
4.Salivary cortisol
5.Heart rate variability (LF/HF ratio: by testing device)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

GroupA(placebo-rest-100mg-rest-300 mg)
5weeks.

Interventions/Control_2

GroupB(300mg-rest-100mg-rest-placebo)
5weeks.

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

35

years-old

<=

Age-upper limit

50

years-old

>=

Gender

Male

Key inclusion criteria

1) Age: 35 to 50 years old (at the time of obtaining consent)
2) Gender: Male
3) Inpatient/Outpatient: Outpatient
4) Healthy subjects (In this study, healthy subjects are defined as those who do not have any serious organ disorder or specific disease, who are not receiving any related treatment, and who are not receiving any medication. 5) Systolic blood pressure is 101.5 mg/kg.
5) Systolic blood pressure between 101 mmHg and 139 mmHg, and diastolic blood pressure between 61 mmHg and 89 mmHg
6) Patients who can consume the test food for three 7-day periods (21 days) (including a 2-week rest period)
7) Patients whose diet or exercise regimen, if any, will not be changed during the study period
8)Those who can give written consent.
9)Those whose daily work is mainly office work (desk work) and who are married.

Key exclusion criteria

1) Those who are taking medication that may affect the test results.
2) Those who may show allergic symptoms to the test foods.
3) Those who have participated in other clinical trials within one month prior to obtaining consent, or those who are currently participating in other clinical trials.
4) Patients with serious diseases [heart failure, myocardial infarction, myocarditis, etc.] (however, this does not apply to patients with pacemakers or other devices that are judged not to affect the study), liver diseases [liver failure symptoms (fulminant hepatitis), liver cirrhosis, liver tumors], renal diseases [nephrotic syndrome, renal failure (acute and chronic), uremia, hydronephrosis], etc., and those who have problems with their general condition
5) Patients with severe anemia
6) Patients who, in the judgment of the study investigator or sub-investigator, are judged to be at increased risk to subjects or for whom there is a possibility of insufficient data being obtained by conducting the study.

Target sample size

8

Name of lead principal investigator

1st name	Kazuhiko
Middle name
Last name	Hazama

Organization

NIPPNCORPORATION

Division name

Innovation Center, Central Research Laboratory

Zip code

243-0041

Address

5-1-3 Midorigaoka, Atsugi City, Kanagawa Prefecture

TEL

046-222-6963

Email

kaida@nippn.co.jp

Name of contact person

1st name	Kazuhiro
Middle name
Last name	Ohno

Organization

CLINICAL CREATIVE CO,LTD

Division name

Pharmaceutical Development Division

Zip code

0620933

Address

1-12-102, Hiragishi 3-13-1-12, Toyohira-ku, Sapporo City, Hokkaido

TEL

09031166218

Homepage URL

Email

k-ohno@cli-creative.com

Institute

Clinical Creative Co., Ltd.

Institute

Department

Personal name

Organization

NIPPNCORPORATION

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Sapporo Yurinokai Hospital Clinical Trial Review Committee

Address

11-186 Yurigahara, Kita-ku, Sapporo-shi, Hokkaido

Tel

011-771-1501

Email

info@yurinokai.jp

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

2021

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2021

Year

04

Month

19

Day

Date of IRB

2021

Year

04

Month

21

Day

Anticipated trial start date

2021

Year

07

Month

01

Day

Last follow-up date

2021

Year

08

Month

07

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

06

Month

29

Day

Last modified on

2021

Year

10

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051057