UMIN-CTR Clinical Trial

Basic information
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
Condition	healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

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	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

Eligibility
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

Research contact person
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

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
Institute	Clinical Creative Co., Ltd.
Institute
Department

Funding Source
Organization	NIPPNCORPORATION
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	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
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	2021 Year 07 Month 01 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	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
Other related information

Management information
Registered date	2021 Year 06 Month 29 Day
Last modified on	2021 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051057