Clinical trial NCT05329675: Trial of Sinphar Lipucan Capsule to Regulate Immune Function
Official title: Phase II Clinical Trial of Sinphar Lipucan Capsule: the Regulation of Immune Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition, Healthy
Keywords: Lipucan
Immune
Acute Upper Respiratory Tract Infection
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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。
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximal CD25/69 Activation (% of NK CD25/69+ Cells)
timeFrame: 0 day, 30th day, and 90th day
Secondary outcomes:
measure: Maximal Levels of IFN-α(pg/ml)
timeFrame: 0 day, 30th day, 90th day, 180th day and 270th day
measure: Maximal Levels of IFN-γ(pg/ml)
timeFrame: 0 day, 30th day, 90th day, 180th day and 270th day
measure: Maximal Levels of IgG, IgA, IgE (mg/dL)
timeFrame: 0 day, 30th day, 90th day, 180th day and 270th day
measure: Number of Upper Respiratory Infections
timeFrame: 0 day, 30th day, 90th day, 180th day and 270th day
measure: Number of Lower Respiratory Infections
timeFrame: 0 day, 30th day, 90th day, 180th day and 270th day
measure: Number of Influenza-like Illnesses
timeFrame: 0 day, 30th day, 90th day, 180th day and 270th day
measure: Number of Urinary Tract Infections
timeFrame: 0 day, 30th day, 90th day, 180th day and 270th day
measure: Number of Other Infections
timeFrame: Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day
measure: Fatigue Severity Scale (FSS)
timeFrame: 0 day, 30th day, 90th day, 180th day and 270th day
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia University
state: Please Select
Study officials:
affiliation: Asia University, Taiwan
name: Szu-Yuan Wu
role: STUDY_DIRECTOR
References: