NCT05329675

Brief Summary

Trial of Sinphar Lipucan Capsule to regulate immune function

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

November 17, 2022

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

April 7, 2022

Last Update Submit

November 13, 2022

Conditions

Nutrition, Healthy

Keywords

LipucanImmuneAcute Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Maximal Levels of IFN-α(pg/ml)

    0 day, 30th day, 90th day, 180th day and 270th day

  • Maximal Levels of IFN-γ(pg/ml)

    0 day, 30th day, 90th day, 180th day and 270th day

  • Maximal Levels of IgG, IgA, IgE (mg/dL)

    0 day, 30th day, 90th day, 180th day and 270th day

  • Number of Upper Respiratory Infections

    0 day, 30th day, 90th day, 180th day and 270th day

  • Number of Lower Respiratory Infections

    0 day, 30th day, 90th day, 180th day and 270th day

  • +4 more secondary outcomes

Study Arms (3)

Arm A

SHAM COMPARATOR

one capsule /day

Dietary Supplement: Sinphar Lipucan Capsule

Arm B

EXPERIMENTAL

two capsule/day

Dietary Supplement: Sinphar Lipucan Capsule

Arm C

EXPERIMENTAL

Three capsule /day

Dietary Supplement: Sinphar Lipucan Capsule

Interventions

Sinphar Lipucan CapsuleDIETARY_SUPPLEMENT

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

Arm AArm BArm C

Eligibility Criteria

Age20 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details20-65 years old
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Healthy Volunteers

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asia University

Taichung, Please Select, 116, Taiwan

RECRUITING

Study Officials

  • Szu-Yuan Wu

    Asia University, Taiwan

    STUDY DIRECTOR

Central Study Contacts

Szu-Yuan Wu, MD, PhD

CONTACT

+886910603955szuyuanwu5399@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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。
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 15, 2022

Study Start

April 1, 2022

Primary Completion

April 30, 2024

Study Completion

April 30, 2025

Last Updated

November 17, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Study Protocol Sharing

Shared Documents
STUDY PROTOCOL
Time Frame
4/30/2025
Access Criteria
requirement with an official application

Locations

TW(1)