evaluate the safety and immunomodulatory efficacy of Byolic CC supplement
Phase 1
Recruiting
- Conditions
- Immunomodulatory effect on healthy volunteers.
- Registration Number
- IRCT20240304061158N4
- Lead Sponsor
- Behpad Teb Iranian
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Health of volunteers
Exclusion Criteria
usage of immunosuppressive drugs, including cytotoxic drugs and corticosteroids, or any other drug (within 4 weeks before the start of the study) that may interfere with the supplement used in this study (or other herbal products)
drug and food allergies
pregnancy and lactation
cardiovascular, kidney, lung, liver, endocrine, hematological, neurological or psychiatric diseases, etc.)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety check variables:Physical examination, vital signs and laboratory measurements including blood biochemistry (BC) and complete blood count (CBC). Timepoint: Day 0,30,60. Method of measurement: Physical examination, Blood test.;Variables for investigating the immunomodulatory effect: Measuring the levels of cytokines TNF-a and IL-12 in serum samples by ELISA method, Measuring the level of cytokine IFN-? in the supernatant, Measuring the proliferation and activation of NK cells by flow cytometry using FITC-a-human CD56 and PE-a-human CD314 (NKG2D) antibodies. Timepoint: Day 0 and 60. Method of measurement: Serum sample analyze.
- Secondary Outcome Measures
Name Time Method