A 8 week, randomized, double-blind, Placebo-controlled clinical trial of extracted Canavalia of complex for the for the for the evaluation of efficacy and safety on immune functio
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0002757
- Lead Sponsor
- AEKYUNG Industry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1) Male or female subjects aged from 25 to 75 years old.
2) Screening white blood cell(WBC) ranged from 3000 to 8000 cells/ul.
3) Stress self assessment scaled above "strong"(4 scales: none, moderate, strong, intense)
4) Subjects suffered from upper respiratory track infection or cold-related symptoms which have possibilities to cause upper respiratory track infection more than two times in the past one year. (*Tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc.)
5) Subjects who agreed to participate in this study and subjects(or legal representative) who signed written informed consent voluntarily.
1) Subjects who have past history or currently in the treatment of significant clinical disease related to acute or chronic cardiovascular system, immune system, respiratory system, liver biliary, kidney and urinary tract, nervous system, musculoskeletal disorders, psychic, infection and blood neoplastic.
(However, subjects are possible to participate in the study by the discretion of the study director)
2) Subjects who have uncontrolled high blood pressure. (Higher than 160/100mmHg, measured 10 minutes after stabilizing)
3) diabetes patients (fasting glucose level that is more than normal of this organization or had been taking or currently are taking a drug due to diabetes in the past
4) Subjects who got a vaccination within 3 months before screening.
5) Subjects whose AST (GOT) or ALT (GPT) higher than 3 times of normal upper limit in the blood.
6) Subjects whose creatinine exceeds 3 times of normal upper limit in the blood
7) Subjects who had intaken or is intaking functional foods that have potential of affecting the immune system whitin 2 weeks s before screening.
8) Subjects who have complained of severe gastrointestinal symptoms such as heartburn, indigestion.
9) Subjects who are planning a pregnancy, breastfeeding during this study.
10) Subjects who are planning to participate other studies during this study.
11) Subjects who were involved in other human applied studies within 8 weeks of this study begins.
12) Subjects who are deemed to be inappropriate to this human applied study.
13) Subjects who are sensitive to foods or have food allergies.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method K cell activity (E:T ratio 12.5:1, 25:1, 50:1);Phagocytosis;Interferon-?, Interleukin-2, Interleukin-10, Interleukin-12, Immunoglobulin A, Cortisol, Serotonin;White Blood Cell count;participant's self evaluation regarding their health improvement
- Secondary Outcome Measures
Name Time Method advers event;clinical pathology examination;vital sign (blood pressure, heart rate, body temperature), weight