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
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0007832
- Lead Sponsor
- Jeonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method atural Killer cell activity
- Secondary Outcome Measures
Name Time Method Cytokines;Global Assessment of Recent Stress Scale