Trial of Sinphar Lipucan Capsule to Regulate Immune Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2025-04-30

Brief Summary

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Trial of Sinphar Lipucan Capsule to regulate immune function

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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.

Conditions

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Nutrition, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm A

one capsule /day

Group Type SHAM_COMPARATOR

Sinphar Lipucan Capsule

Intervention Type DIETARY_SUPPLEMENT

oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days

Arm B

two capsule/day

Group Type EXPERIMENTAL

Sinphar Lipucan Capsule

Intervention Type DIETARY_SUPPLEMENT

oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days

Arm C

Three capsule /day

Group Type EXPERIMENTAL

Sinphar Lipucan Capsule

Intervention Type DIETARY_SUPPLEMENT

oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days

Interventions

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Sinphar Lipucan Capsule

oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes