Human study to evaluate efficacy and safety of red balloon flower root extract on enhancement of immune functio
- Conditions
- Not Applicable
- Registration Number
- KCT0005945
- Lead Sponsor
- Gachon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1. Adult men and women aged =20 and <75 years
2. Subjects who agreed to participate in this study and sign the informed consent
1. Subjects with WBC <3,000 cells/µl or >10,000 cells/µl in the screening test
2. Subjects with BMI <18.5kg kg/m2 or >35 kg/m2 in the screening test
3. When it is not possible to perform the test conducted in the human study
4. Subjects who have the following symptoms/diseases or history
- Subjects who have a medical history of gastrointestinal diseases (Crohn's disease, etc.) or operation (except appendectomy or herniotomy)
- Uncontrolled diabetic patients (Fasting blood glucose = 180 mg/dL or in the case of medication changed or started anew within three months)
- Uncontrolled hypertension patients (blood pressure = 160/100 mmHg or in the case of medication changed or started anew within three months)
- Subjects with acute severe cardiovascular disease such as heart failure, myocardial infarction, and stroke
- Subjects who have immune system disease or severe liver failure, renal failure or history
- Subject who have thyroid gland or pituitary gland disease
- Subjects who have systemic diseases such as malignant tumors, lung diseases, leukemia, collagenosis, multiple sclerosis, allergic skin diseases and other autoimmune diseases or history
5. Subject who show the following results in the screening test
- AST, ALT > more than 2 times of the upper limit
- Abnormal kidney function:
Serum creatinine > 2.0 mg/dL
6. Subject who get a medical history of psychopharmacotherapy with in last 2 months before screening test
7. Subject who have experienced taking medicines, herbal medicines, and health functional foods that may affect their immune system within two weeks prior to the first intake of the experimental food (the health functional foods can be participated after a week's recess before the first intake of the clinical product)
8. When the use of prohibited drugs is expected during the study period
9. Subjects who have hypersensitivity history due to experimental product or ingredients
10. Subject who were participated in other clinical trials within the previous two months
11. In the case of continuous consumption of food or processed food from raw material for experimental food within 2 weeks
12. Pregnant or lactating women
13. Subject who do not perform adequate contraception in women of childbearing age (except woman who undergo sterilization operation)
14. Subject who deemed inappropriate to participate this clinical trial by research director due to other reasons including screening test
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method K cell activity
- Secondary Outcome Measures
Name Time Method Interleukin-6, Interleukin-12;Interferon-?