Nutrition, Healthy
Conditions
Keywords
Lipucan, Immune, Acute Upper Respiratory Tract Infection
Brief summary
Trial of Sinphar Lipucan Capsule to regulate immune function
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSinphar Lipucan Capsule
oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Study Type : Interventional (Clinical Trial) Actual Enrollment : 108 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status Primary Purpose: Number of NK cells。
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
\- Healthy Volunteers
Exclusion criteria
1. Evidence of chronic cardio-pulmonary disease, immune-suppression or any chronic systemic disease or disability 2. Positive pregnancy test or currently breastfeeding 3. History of autoimmune disease 4. History of allergic rhinitis 5. History of physician diagnosed eczema 6. Known allergic reaction to Poria cocos or related species, 7. Pregnancy or currently breastfeeding. 8. History of autoimmune disease or immune disorders. 9. History of asthma. 10. History of allergic rhinitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal CD25/69 Activation (% of NK CD25/69+ Cells) | 0 day, 30th day, and 90th day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Levels of IFN-γ(pg/ml) | 0 day, 30th day, 90th day, 180th day and 270th day | 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. |
| Maximal Levels of IgG, IgA, IgE (mg/dL) | 0 day, 30th day, 90th day, 180th day and 270th day | 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. |
| Number of Upper Respiratory Infections | 0 day, 30th day, 90th day, 180th day and 270th day | Diagnosed by professional otorhinolaryngologists or Family medicine doctors |
| Number of Lower Respiratory Infections | 0 day, 30th day, 90th day, 180th day and 270th day | Diagnosed by professional otorhinolaryngologists, chest medicine doctors, or Family medicine doctors |
| Maximal Levels of IFN-α(pg/ml) | 0 day, 30th day, 90th day, 180th day and 270th day | 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. |
| Number of Urinary Tract Infections | 0 day, 30th day, 90th day, 180th day and 270th day | Diagnosed by professional Genitourinary doctors, or Family medicine doctors |
| Number of Other Infections | Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day | Diagnosed by professional Family medicine doctors |
| Fatigue Severity Scale (FSS) | 0 day, 30th day, 90th day, 180th day and 270th day | Estimated by the research nurse (Scale 9-63) |
| Number of Influenza-like Illnesses | 0 day, 30th day, 90th day, 180th day and 270th day | Diagnosed by professional otorhinolaryngologists, chest medicine doctors, or Family medicine doctors |
Countries
Taiwan
Contacts
Primary ContactSzu-Yuan Wu, MD, PhD
Outcome results
None listed