Pharmacokinetic Profile of Rosemary Extract Supplement | NCT05931341

Studies
Pharmacokinetic Profile of Rosemary Extract Supplement

NCT05931341

Sponsor

CJ CheilJedang

Status

Unknown status

Last Update Posted

Nov 22, 2023Actual

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Pharmacokinetics

Interventions

Rosemary extract

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Mar 1, 2024Estimated

Completion Date

May 1, 2024Estimated

First Submitted Date

Jun 26, 2023

First Submission Date that Met QC Criteria

Jul 3, 2023

First Posted Date

Jul 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2023

Last Update Posted Date

Nov 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a clinical trial to observe changes in biomarkers in the blood at pre- and post-supplementation of rosemary extract in healthy adults.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Dosage 1	Experimental	Dietary Supplement: Rosemary extract
Dosage 2	Experimental	Dietary Supplement: Rosemary extract
Dosage 3	Experimental	Dietary Supplement: Rosemary extract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rosemary extract	Dietary Supplement	Softgel capsule including rosemary extract	Dosage 1 Dosage 2 Dosage 3

Measure	Description	Time Frame
Concentration in plasma		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects aged between 25 and 55 years
Non-smoker
Body Mass Index (BMI) between 20 and 30 kg/m2

Exclusion Criteria:

Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, endocrine, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000713808	rosemary leaf extract

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided