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

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

Trial of Sinphar Lipucan Capsule to regulate immune function

Study Overview

• Status: Recruiting
• Conditions: Nutrition, Healthy
• Intervention / Treatment: Dietary supplement: Sinphar Lipucan Capsule

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.

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Szu-Yuan Wu, MD, PhD; Phone Number: +886910603955; Email: szuyuanwu5399@gmail.com

Study Locations

• Taiwan
  • Please Select
    • Taichung, Please Select, Taiwan, 116
      • Recruiting
      • Asia university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Arm A; one capsule /day	Dietary supplement: Sinphar Lipucan Capsule; oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days
EXPERIMENTAL: Arm B; two capsule/day	Dietary supplement: Sinphar Lipucan Capsule; oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days
EXPERIMENTAL: Arm C; Three capsule /day	Dietary supplement: Sinphar Lipucan Capsule; oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2022
• Primary Completion (ANTICIPATED): April 30, 2024
• Study Completion (ANTICIPATED): April 30, 2025

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (ACTUAL): April 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Immune; Acute Upper Respiratory Tract Infection; Lipucan
• Other Study ID Numbers: IRB110-149-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol Sharing
• IPD Sharing Time Frame: 4/30/2025
• IPD Sharing Access Criteria: requirement with an official application
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No