UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047500
Receipt number R000054169
Scientific Title A randomized, double-blind, parallel-group study of rosemary materials
Date of disclosure of the study information 2022/05/12
Last modified on 2023/04/07 12:54:46

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Basic information

Public title

Rosemary anti-stress main study

Acronym

Rosemary anti-stress main study

Scientific Title

A randomized, double-blind, parallel-group study of rosemary materials

Scientific Title:Acronym

A randomized, double-blind, parallel-group study of rosemary materials

Region

Japan


Condition

Condition

healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To test whether rosemary extract has an anti-stress effect.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.POMS2
2.Salivary amylase
3.Salivary cortisol
4.Heart rate variability (LF/HF ratio: based on testing equipment)

Key secondary outcomes

1.The OSA-MA (Onset Sleep Interval Questionnaire)


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

Prevention

Type of intervention

Food

Interventions/Control_1

Duration.4 weeks
Test food.rosemary extract
Dosage and Administration.Take 2 rosemary extract capsules after breakfast.

Interventions/Control_2

Duration.4 weeks
Test food.placebo
Dosage and Administration.Take 2 placebo capsules after breakfast.

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

20 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Age: 20 to 60 years old (at the time of obtaining consent)
2.Gender: male/female
3.Inpatient/outpatient: Outpatient
4.Healthy subjects (Healthy subjects in this study are those who do not have any serious organ damage or specific diseases and are not receiving any treatment related to them or any drug therapy. Whether or not a person falls under the category of "healthy subjects" is based on the person's declaration at the time of the start of the examination.)
5.Systolic blood pressure between 101 mmHg and 139 mmHg and diastolic blood pressure between 61 mmHg and 89 mmHg.
6.Those who are able to consume the test food for 28 days.
7.If on a diet or exercise regimen, do not change it during the study period.
8.Those who give written consent.
9.Those with a simple stress level check test score (1-13) in the middle of the range.

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 food.
3.Those who have participated in other clinical trials within one month prior to obtaining consent or are currently participating in other clinical trials.
4. Critical illness [heart failure, myocardial infarction, myocarditis, etc.] (however, this does not apply if it is determined that a pacemaker or other device will not affect the study), liver disease [hepatic failure symptoms (fulminant hepatitis), cirrhosis, liver tumor], renal disease [nephrotic syndrome, renal failure (acute and chronic), uremia, hydronephrosis], etc. Complications and general health problems.
5.Patients with severe anemia
6.Subjects for whom, in the judgment of the study investigator or subinvestigator, there is a possibility of increased risk to the subject or inadequate data to be obtained by conducting the study.
7.Those who work at night or in rotating shifts
8.Those who regularly drink energy drinks
9.Those using health foods, supplements, and medications that affect stress, cognitive function
10.Those who consume rosemary supplements or a diet with large amounts of rosemary.

Target sample size

44


Research contact person

Name of lead principal investigator

1st name Kazuhiko
Middle name
Last name Aida

Organization

NIPPN CORPORATION

Division name

Innovation Center, Central Research Laboratory

Zip code

2430041

Address

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

TEL

046-222-6963

Email

kaida@nippn.co.jp


Public contact

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


Sponsor or person

Institute

Clinical Creative Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

NIPPN CORPORATION

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical Corporation Association Sapporo Yurinokai Hospital

Address

11-186 Yurigahara, Kita-ku, Sapporo, Japan

Tel

011-771-1501

Email

info@yurinokai.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

医療法人社団 札幌百合の会病院
Medical Corporation Association Sapporo Yurinokai Hospital


Other administrative information

Date of disclosure of the study information

2022 Year 05 Month 12 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 03 Month 30 Day

Date of IRB

2022 Year 04 Month 06 Day

Anticipated trial start date

2022 Year 05 Month 12 Day

Last follow-up date

2022 Year 06 Month 11 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 04 Month 15 Day

Last modified on

2023 Year 04 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054169


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name