UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044702 |
|---|---|
| Receipt number | R000051057 |
| Scientific Title | A randomized, placebo-controlled, double-blind, three-dose, crossover study |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/10/13 11:11:55 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051057
