UMIN-CTR Clinical Trial

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
Institute	Clinical Creative Co., Ltd
Institute
Department

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	Preinitiation
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	2022 Year 04 Month 15 Day

Link to view the page
URL(English)	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

Contact us.