None listed
Conditions
Interventions
Dietary Supplement : - experimental group 50 subjects / placebo group 50 subjects
* usage and capacity
- intake 3 capsules/time and 3 times a day (9 capsules / day)
- intake before meals (breakfast,
Sponsors
Chonbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female subject aged between 39 years and 70 years 2) subjects who decided to voluntarily participate in this clinical trial and complete to sign on the informed consent
Exclusion criteria
Exclusion criteria: 1) subjects who got a vaccination within 6 months before screening 2) subjects who got any vaccination within 1 months from screening or will sceduled vaccination in the intake period(8 weeks) 3) subjects who got immunosuppressant or immunemodifying drug within in the 3 months from screening ? such as Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus,Everolimus, Sirolimus, Cyclophophamid, 6-mercaptopurine, Methotrexate, Rapamycin, Leflunomide ? subjects who had received steroid more than 14 days within 3 months of screening 4) subjects who had received or are scheduled to receive those products ( Immunoglobulin or blood-derived product ) within 3 months from screening 5) subject who got the psychotropic drugs and narcotic analgesic drugs within 6 months of screening 6) subjects who have a history of hypersensitivity about vaccination such as Guillang-Barre syndrome 7) hemophilia patients at risk of serious bleeding with intramuscular injection or who had taken an anticoagulant 8) subjects who have other clinically significant medical history of liver-biliary system, renal system, nervous system(central or peripheral), respiratory system(asthma, etc.), endocrine system(diabetes, hyperlipidemia, etc.), cardiovascular system(congestive heart failure, coronary heart disease, myocardial infarction, uncontrollable hypertension, etc.), blood tumor, urinary system, psychiatry, musculoskeletal system, immune system(rheumatoid arthritis, systemic lupus erythematosus, etc.) or who were considered by the investigator to be ineligible for the study 9) subjects who have hypersensitive or clinically significant hypersensitivity history due to drug, experimental product((Aloe vera gel), influenza vaccination and Other ingredients(formalin, etc.) 10) subjects who are suspected drug abuse or have a medical history of dependent on drug 11) subjects who have a medical history of gastrointestinal diseases(Crohn's disease, etc.) or operation(except appendectomy or herniotomy) 12) subject who drink constantly(21 units/week excess) or have a medical history of dependent on alcohol abuse 13) subject who show the following results in the screening test ? AST, ALT > more than 2 times of the upper limit ? Serum creatinine > 2.0 mg/dL 14) subjects who involved in other clinical trial within 2 months before screening test 15) subjects who are planning a pregnancy or are breastfeeding during this study 16) subject who do not perform adequate contraception(using a condom, contraceptive diaphragm, intrauterine contraceptive device from 21 days before vaccination with the investigational product or whose male partner had undergone a vasectomy) in the urban eligible women 17) subject who deemed inappropriate to participate this clinical trial by research director due to other reasons including screening test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroprotection rate of HI antibody | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency, severity, and duration of URI;GMT increase fold of antibody titer;Seroconversion rate;Seroprotection rate;INF-? producing cell | — |
Countries
Korea, Republic of
Contacts
Public ContactMI-RA Oh
Chonbuk National University Hospital
Outcome results
None listed