Trial of Sinphar Lipucan Capsule to Regulate Immune Function

Study Overview
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Brief Summary
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Trial of Sinphar Lipucan Capsule to regulate immune function

Detailed Description
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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.

Official Title
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Phase II Clinical Trial of Sinphar Lipucan Capsule: the Regulation of Immune Function

Conditions
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Nutrition, Healthy

Intervention / Treatment
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* Dietary Supplement: Sinphar Lipucan Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Healthy Volunteers Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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。
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Arm A<br>one capsule /day | Dietary Supplement: Sinphar Lipucan Capsule<br>* oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days<br>|
| Experimental: Arm B<br>two capsule/day | Dietary Supplement: Sinphar Lipucan Capsule<br>* oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days<br>|
| Experimental: Arm C<br>Three capsule /day | Dietary Supplement: Sinphar Lipucan Capsule<br>* oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipucan, Immune, Acute Upper Respiratory Tract Infection