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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000047500 |
Receipt No. | 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 | 2022/04/15 |
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 |
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Condition | ||
Condition | healthy person | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Duration.4 weeks
Test food.rosemary extract Dosage and Administration.Take 2 rosemary extract capsules after breakfast. |
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Interventions/Control_2 | Duration.4 weeks
Test food.placebo Dosage and Administration.Take 2 placebo capsules after breakfast. |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 44 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Anticipated trial start date |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |