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Rosemary anti-stress main study

A randomized, double-blind, parallel-group study of rosemary materials - A randomized, double-blind, parallel-group study of rosemary materials

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047500
Enrollment
44
Registered
2022-05-12
Start date
2022-05-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy person

Interventions

Duration.4 weeks Test food.rosemary extract Dosage and Administration.Take 2 rosemary extract capsules after breakfast. Duration.4 weeks Test food.placebo Dosage and Administration.Take 2 placeb

Sponsors

Clinical Creative Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
1.POMS2 2.Salivary amylase 3.Salivary cortisol 4.Heart rate variability (LF/HF ratio: based on testing equipment)

Secondary

MeasureTime frame
1.The OSA-MA (Onset Sleep Interval Questionnaire)

Countries

Japan

Contacts

Public ContactKazuhiro Ohno

Clinical Creative Co., Ltd. Pharmaceutical Development Division

k-ohno@cli-creative.com09031166218

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026