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

November 13, 2022 updated by: Taipei Medical University WanFang Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximal CD25/69 Activation (% of NK CD25/69+ Cells)
Time Frame: 0 day, 30th day, and 90th day
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximal Levels of IFN-α(pg/ml)
Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day
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)
Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day
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)
Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day
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
Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day
Diagnosed by professional otorhinolaryngologists or Family medicine doctors
0 day, 30th day, 90th day, 180th day and 270th day
Number of Lower Respiratory Infections
Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day
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
Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day
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
Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day
Diagnosed by professional Genitourinary doctors, or Family medicine doctors
0 day, 30th day, 90th day, 180th day and 270th day
Number of Other Infections
Time Frame: Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day
Diagnosed by professional Family medicine doctors
Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day
Fatigue Severity Scale (FSS)
Time Frame: 0 day, 30th day, 90th day, 180th day and 270th day
Estimated by the research nurse (Scale 9-63)
0 day, 30th day, 90th day, 180th day and 270th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University WanFang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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