A 12-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Angelica gigas Nakai extract(AGE232) on improvement of blood flow

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008623

Enrollment

100

Registered

2023-07-17

Start date

2022-06-08

Completion date

Unknown

Last updated

2023-08-01

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 : 2 tablets a time, twice a day, 12 weeks - Angelica gigas Nakai extract (AGE232): 3,200mg/day (Extract Powder of Angelica gigas Nakai 1,600mg/day) - Placebo: 3,200mg/day (Extra of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male or female subjects aged from 25 to 70 years old 2) Those who satisfy 3 or more criteria ? Subjects who 200~239 mg/dL of fasting total-cholesterol ? Subjects who130~159 mg/dL of fasting LDL-cholesterol ? Subjects who 100~125 mg/dL of fasting blood sugar ? Subjects who 120~139 mmHg of systolic blood pressure ? Subjects who BMI 25~29.9 kg/m2 of BMI ? Subjects who male 0.9, female 0.85 of WHR

Exclusion criteria

Exclusion criteria: 1) Subjects who have disorders in platelet function and platelet coagulation 2) Subjects who BMI 25~29.9 kg/m2 of BMI 3) Subjects who have taken medications or dietary supplements related to platelet function, blood circulation improvement, and hyperlipidemia within 4 weeks before study enrollment 4) Subjects who Alcoholism (21 units/week) or substance abuse or dependence 5) Subjects who have an overreaction to the ingredients contained in the human body application test product 6) Women undergoing hormone replacement therapy 7) Participation in other clinical trials within the previous three months 8) Subjects who are pregnant and breastfeeding female 9) Subjects who do not perform adequate contraception in the urban eligible women (except the woman who undergo sterilization operation) 10) Subject who was deemed inappropriate to participate in this clinical trial by the research director due to other reasons including screening test

Design outcomes

Primary

Measure	Time frame
platelet aggregation(PFA);Peripheral arterial tonometry	—

Secondary

Measure	Time frame
Oxidized LDL;Thromboxane B2, e-NOS, COX-2;TC, TG, HDL-C, LDL-C	—

Countries

Korea, Republic of

Contacts

Public ContactHui Yeon Jang

Jeonbuk National University Hospital

janghy@jbctc.org+82-63-259-3046

Outcome results