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
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
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
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
