A human study to evaluate the bioavailability, anti-inflammation, and safety of Agastache rugosa extracts in healthy women aged more than 20 years and less than 30 years old.

A human study to evaluate the bioavailability, anti-inflammation, and safety of Agastache rugosa extracts in healthy women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006656

Enrollment

Registered

2021-10-08

Start date

2020-09-18

Completion date

Unknown

Last updated

2021-11-02

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

Conditions

None listed

Interventions

Dietary Supplement : After 2-week run-in period, subjects are randomly assigned to one of the two sequence. Each sequence is consist of intervention groups (control group or Agastache rugosa extracts

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Subject who voluntarily agree to participate and signs informed consent form 2) Subject who can participate in all visits (total of twice) after random assignment. 2) healthy women aged over 20 years old and under 40 years old

Exclusion criteria

Exclusion criteria: 1) presence of disease : chronic inflammatory disease, diabetes, liver or kidney disease, cardiovascular disease, uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg), or thyroid disease, etc. 2) taking medication and oriental medicine that may affect antioxidant/anti-inflammatory properties, blood glucose and blood lipids within the preceding 4 weeks 3) continuous consumption of dietary supplements within the preceding 4 week 4) body mass index (BMI) of less than 18.5 kg/m2 or greater than 30 kg/m2 5) a history of body weight change = 4 kg within the preceding 4 weeks 6) alcoholism 7) smokers 8) subjects were unable to maintain their current lifestyle (exercise, diet, etc.) during the exam period 9) participation in another clinical trial within the preceding 4 weeks 10) pregnancy or lactation 11) hypersensitivity to Agastache rugosa or any ingredients in the study product 12) investigator’s determination of unsuitability for the trial

Design outcomes

Primary

Measure	Time frame
Targeted metabolomics	—

Secondary

Measure	Time frame
Proteomics;Biochemical markers: glucose, insulin, triglycerides, total cholesterol, free fatty acids etc.	—

Countries

Korea, Republic of

Contacts

Public ContactEunok Lee

Ewha Womens University

flffl0204@naver.com+82-2-3277-3087

Outcome results