Nutrition, HealthyTSLCNCT05329675
Trial of Sinphar Lipucan Capsule to Regulate Immune Function
A study testing Sinphar Lipucan Capsule in people with Nutrition, Healthy, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Trial of Sinphar Lipucan Capsule to regulate immune function Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Sinphar Lipucan Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers
Who cannot join
- 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,
Show all 10Show fewer
- Pregnancy or currently breastfeeding.
- History of autoimmune disease or immune disorders.
- History of asthma.
- History of allergic rhinitis.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Asia University
Taichung, Please Select, 116
Szu-Yuan Wu, MD, PhD., 0910603955, szuyuanwu5399@gmail.com
About this study
Official title: Phase II Clinical Trial of Sinphar Lipucan Capsule: the Regulation of Immune Function
Trial of Sinphar Lipucan Capsule to regulate immune function
Read the 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.
- Conditions
- Nutrition, Healthy
- Being tested
- Sinphar Lipucan Capsule
- Keywords
- Lipucan, Immune, Acute Upper Respiratory Tract Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinphar Lipucan CapsuleDietary supplement
oral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Sham comparator | one capsule /day Receives: Dietary Supplement: Sinphar Lipucan Capsule |
| Arm B | Experimental | two capsule/day Receives: Dietary Supplement: Sinphar Lipucan Capsule |
| Arm C | Experimental | Three capsule /day Receives: Dietary Supplement: Sinphar Lipucan Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 day, 30th day, and 90th day
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 0 day, 30th day, 90th day, 180th day and 270th day
Number of Upper Respiratory Infections
Diagnosed by professional otorhinolaryngologists or Family medicine doctors
Measured: 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
Measured: 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
Measured: 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
Measured: 0 day, 30th day, 90th day, 180th day and 270th day
Number of Other Infections
Diagnosed by professional Family medicine doctors
Measured: 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)
Measured: 0 day, 30th day, 90th day, 180th day and 270th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Apr 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Szu-Yuan Wu, Study director, Asia University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329675
- Sponsor's protocol ID
- IRB110-149-A
- Acronym
- TSLC
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Sharing
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Sinphar Lipucan Capsule: the Regulation of Immune Function
- ClinicalTrials.gov ID
- NCT05329675
- Acronym / sponsor ID
- TSLC / IRB110-149-A
- Conditions
- Nutrition, Healthy
- Keywords
- Lipucan, Immune, Acute Upper Respiratory Tract Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trial of Sinphar Lipucan Capsule to regulate immune function
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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。
| Arm | Type | Receives |
|---|---|---|
| Arm A | Sham comparator | Dietary Supplement: Sinphar Lipucan Capsuleone capsule /day |
| Arm B | Experimental | Dietary Supplement: Sinphar Lipucan Capsuletwo capsule/day |
| Arm C | Experimental | Dietary Supplement: Sinphar Lipucan CapsuleThree capsule /day |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Volunteers
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinphar Lipucan Capsuleoral Sinphar Lipucan Capsule 1# (Arm A), 2# (Arm B), or 3# (Arm C)/day for 90 days | Dietary supplement | Arm A, Arm B, Arm C |
Primary outcome
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
9 secondary outcomes
Maximal Levels of IFN-α(pg/ml)
Time frame: 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
Maximal Levels of IgG, IgA, IgE (mg/dL)
Time frame: 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
Number of Lower Respiratory Infections
Time frame: 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
Number of Urinary Tract Infections
Time frame: 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
Fatigue Severity Scale (FSS)
Time frame: 0 day, 30th day, 90th day, 180th day and 270th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: Yes. Study Protocol Sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Szu-Yuan Wu study director
Asia University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinphar Lipucan Capsule in people with Nutrition, Healthy, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Szu-Yuan Wu, MD, PhD (+886910603955, szuyuanwu5399@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal CD25/69 Activation (% of NK CD25/69+ Cells) (time frame: 0 day, 30th day, and 90th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.