Phase II Clinical Trial of Sinphar Lipucan Capsule: the Regulation of Immune Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Maximal CD25/69 Activation (% of NK CD25/69+ Cells)
研究概览
简要总结
Trial of Sinphar Lipucan Capsule to regulate immune function
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
排除标准
- •Evidence of chronic cardio-pulmonary disease, immune-suppression or any chronic systemic disease or disability
- •Positive pregnancy test or currently breastfeeding
- •History of autoimmune disease
- •History of allergic rhinitis
- •History of physician diagnosed eczema
- •Known allergic reaction to Poria cocos or related species,
- •Pregnancy or currently breastfeeding.
- •History of autoimmune disease or immune disorders.
- •History of asthma.
- •History of allergic rhinitis.
结局指标
主要结局
Maximal CD25/69 Activation (% of NK CD25/69+ Cells)
时间窗: 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
次要结局
- Maximal Levels of IgG, IgA, IgE (mg/dL)(0 day, 30th day, 90th day, 180th day and 270th day)
- Number of Urinary Tract Infections(0 day, 30th day, 90th day, 180th day and 270th day)
- Fatigue Severity Scale (FSS)(0 day, 30th day, 90th day, 180th day and 270th day)
- Maximal Levels of IFN-γ(pg/ml)(0 day, 30th day, 90th day, 180th day and 270th day)
- Number of Influenza-like Illnesses(0 day, 30th day, 90th day, 180th day and 270th day)
- Number of Other Infections(Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day)
- Maximal Levels of IFN-α(pg/ml)(0 day, 30th day, 90th day, 180th day and 270th day)
- Number of Lower Respiratory Infections(0 day, 30th day, 90th day, 180th day and 270th day)
- Number of Upper Respiratory Infections(0 day, 30th day, 90th day, 180th day and 270th day)