Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Sham Comparator | one capsule /day |
|
| Arm B | Experimental | two capsule/day |
|
| Arm C | Experimental | Three capsule /day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinphar Lipucan Capsule | Dietary Supplement | oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal 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 | 0 day, 30th day, and 90th day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 day, 30th day, 90th day, 180th day and 270th day |
| Maximal Levels of IFN-γ(pg/ml) |
Not provided
Inclusion Criteria:
- Healthy Volunteers
Exclusion Criteria:
20-65 years old
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Szu-Yuan Wu, MD, PhD | Contact | +886910603955 | szuyuanwu5399@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Szu-Yuan Wu | Asia University, Taiwan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asia University | Recruiting | Taichung | Please Select | 116 | Taiwan |
Study Protocol Sharing
4/30/2025
requirement with an official application
Not provided
Not provided
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。
Not provided
Not provided
Not provided
Not provided
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. |
| 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. | 0 day, 30th day, 90th day, 180th day and 270th day |
| Number of Upper Respiratory Infections | Diagnosed by professional otorhinolaryngologists or Family medicine doctors | 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 | 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 | 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 | 0 day, 30th day, 90th day, 180th day and 270th day |
| Number of Other Infections | Diagnosed by professional Family medicine doctors | 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) | 0 day, 30th day, 90th day, 180th day and 270th day |