Trial of Sinphar Lipucan Capsule to regulate immune function
The immune system is the line of defense for the health of human life entities. If the function decrease, it will reduce the body's defense to outside pathogen and easily lead to the occurrence of diseases. Immune response includes two kinds of reactions: (1) The innate immune system refers to inherited, germ-line defense mechanisms that are directed against molecular components found only in micro-organisms.. (2) The humoral immune response denotes immunologic responses that are mediated by antibodies. Health hazards have always been a trend based on health awareness. Therefore, how to use a healthy diet to promote the immune system is currently the most concerned research direction. Because of the immunomodulatory effect of " Sinphar Lipucan Capsule " in previous animal experiments (1) Promote the secretion of Th1 type cytokine by T cells and inhibit the secretion of Th2 type cytokine; 2) Promote the secretion of IFN-γ by macrophages. 3) Promote the production of OVA antigen-specific antibodies in BALB/c female mice; 4) It can inhibit the secretion of IL-10 cytokine by antigen-specific (OVA) immune cells (that is, inhibit the secretion of Th2 cytokine), we think " Sinphar Lipucan Capsule " may be beneficial in reducing the severity and incidence of Acute Upper Respiratory Tract Infection. Therefore, human clinical trials were started to confirm its clinical effects and immunomodulatory effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
108
oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days
Asia University
Taichung, Please Select, Taiwan
RECRUITINGMaximal CD25/69 Activation (% of NK CD25/69+ Cells)
NK cells with evidence of CD25/69 activation were assessed on 0 day, 30th day, and 3rd month. The highest percentage found on one of these days in each participant was categorized as the the maximal CD25/69 activation
Time frame: 0 day, 30th day, and 90th day
Maximal Levels of IFN-α(pg/ml)
Interferon alpha was measured on 0 day, 30th day, and 90th day in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Time frame: 0 day, 30th day, 90th day, 180th day and 270th day
Maximal Levels of IFN-γ(pg/ml)
IFN-γ(pg/ml) was measured on 0 day, 30th day, and 90th day in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Time frame: 0 day, 30th day, 90th day, 180th day and 270th day
Maximal Levels of IgG, IgA, IgE (mg/dL)
IgG, IgA, IgE (mg/dL) was measured on 0 day, 30th day, and 90th day in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Time frame: 0 day, 30th day, 90th day, 180th day and 270th day
Number of Upper Respiratory Infections
Diagnosed by professional otorhinolaryngologists or Family medicine doctors
Time frame: 0 day, 30th day, 90th day, 180th day and 270th day
Number of Lower Respiratory Infections
Diagnosed by professional otorhinolaryngologists, chest medicine doctors, or Family medicine doctors
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 0 day, 30th day, 90th day, 180th day and 270th day
Number of Influenza-like Illnesses
Diagnosed by professional otorhinolaryngologists, chest medicine doctors, or Family medicine doctors
Time frame: 0 day, 30th day, 90th day, 180th day and 270th day
Number of Urinary Tract Infections
Diagnosed by professional Genitourinary doctors, or Family medicine doctors
Time frame: 0 day, 30th day, 90th day, 180th day and 270th day
Number of Other Infections
Diagnosed by professional Family medicine doctors
Time frame: Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day
Fatigue Severity Scale (FSS)
Estimated by the research nurse (Scale 9-63)
Time frame: 0 day, 30th day, 90th day, 180th day and 270th day