Trial of Sinphar Lipucan Capsule to Regulate Immune Function (TSLC)

Taipei Medical University

Status: Enrolling

Conditions: Nutrition, Healthy

Treatments: Dietary Supplement: Sinphar Lipucan Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05329675

IRB110-149-A

Details and patient eligibility

About

Trial of Sinphar Lipucan Capsule to regulate immune function

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

Arm A

Sham Comparator group

Description:

one capsule /day

Treatment:

Dietary Supplement: Sinphar Lipucan Capsule

Arm B

Experimental group

Description:

two capsule/day

Treatment:

Dietary Supplement: Sinphar Lipucan Capsule

Arm C

Experimental group

Description:

Three capsule /day

Treatment:

Dietary Supplement: Sinphar Lipucan Capsule