A 8 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Angelica gigas N. extract powder(Nutragen) on immune enhancement

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007832

Enrollment

100

Registered

2022-10-21

Start date

2022-07-19

Completion date

Unknown

Last updated

2022-11-28

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 : • Angelica gigas N, extract powder(Nutragen): once a day, 2 tabs once, after meal{1,200 mg/day, Angelica gigas N, extract powder(Nutragen) for 800 mg/day} • Placebo: once a day,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male and female aged 19 or over and 75 or under at the screening examination 2) Participants who had symptoms of upper respiratory infection (cold, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc.) at least twice within 12 months before screening examination 3) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions

Exclusion criteria

Exclusion criteria: 1) Patients who have received vaccination) within two months before ingestion date of investigational product 2) Patients whose BMI is 18.5 kg/m2 under or 35 kg/m2 or over at the screening examination 3) Patients who have clinically significant acute or chronic cardio-cerebrovascular systems, endocrine systems, immune systems, respiratory systems, hepatic biliary systems, kidneys and urinary systems, neuropsychiatric systems, musculoskeletal systems, inflammatory and hematologic and tumorigenic, gastrointestinal diseases, etc. 4) Those who took medicines and health functional foods related to immunity enhancement within one month before the screening examination (refer to combination prohibited drugs) 5) Patients with a history of significant hypersensitivity reaction to the ingredients of Angelica gigas 6) Patients who have received anti-psychotic medication within three months before the screening examination 7) Patients who have or are suspected of alcoholism or substance abuse 8) Patients participated in another clinical trial within three months before the screening examination 9) Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes

Design outcomes

Primary

Measure	Time frame
Natural Killer cell activity	—

Secondary

Measure	Time frame
Cytokines;Global Assessment of Recent Stress Scale	—

Countries

Korea, Republic of

Contacts

Public ContactHui-yeon Jang

Jeonbuk National University Hospital

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

Outcome results