Status Approved
First Submitted Date
2020/09/25
Registered Date
2020/10/12
Last Updated Date
2020/09/25
1. Background
CRIS Registration Number |
KCT0005460 |
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Unique Protocol ID | DJUMC-2020-BM-07 |
Public/Brief Title | A Clinical Trial to Analyze the effect of oral intake of Phellinus linteus(sanghuang) Extract on immune function: Randomized, Double-blind Controlled Trial |
Scientific Title | A Clinical Trial to Analyze the effect of oral intake of Phellinus linteus(sanghuang) Extract on immune function: Randomized, Double-blind Controlled Trial |
Acronym | A Clinical Trial to Analyze the effect of oral intake of Phellinus linteus(sanghuang) Extract on immune function: Randomized, Double-blind Controlled Trial |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | DJUMC-2020-BM-07 |
Approval Date | 2020-08-12 |
Institutional Review Board Name | Cheonan Korean Medicine Hospital of Daejeon university IRB |
Institutional Review Board Address | 4, Notaesan-ro, Seobuk-gu, Cheonan-si, Chungcheongnam-do |
Institutional Review Board Telephone | 041-521-7013 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Jae Hui Kang |
Title | Associate Professor |
Telephone | +82-41-521-7579 |
Affiliation | Daejeon University |
Address | 62 Daehak-ro, Dong-gu, Daejeon |
Contact Person for Public Queries | |
Name | Yong Ho Ku |
Title | Resident |
Telephone | +82-41-521-7579 |
Affiliation | Cheonan Korean Medicine Hospital of Daejeon University |
Address | 4, Notaesan-ro, Seobuk-gu, Cheonan-si, Chungcheongnam-do |
Contact Person for Updating Information | |
Name | Yong Ho Ku |
Title | Resident |
Telephone | +82-41-521-7579 |
Affiliation | Cheonan Korean Medicine Hospital of Daejeon University |
Address | 4, Notaesan-ro, Seobuk-gu, Cheonan-si, Chungcheongnam-do |
4. Status
Study Site | Single | |
---|---|---|
Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-09-25 Anticipated | |
Target Number of Participant | 98 | |
Primary Completion Date | 2021-03-31 , Anticipated | |
Study Completion Date | 2021-03-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Cheonan Korean Medicine Hospital of Daejeon University | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-09-25 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Trade, Industry & Energy |
Organization Type | Government |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Cheonan Korean Medicine Hospital of Daejeon University |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | This clinical trial was designed to evaluate the efficacy and safety of enhancing immune function compared to a control food (Placebo) when ingesting Phellinus linteus(sanghuang) extract in adults with reduced immune function. Human subjects will voluntarily sign the agreement for human application tests, determine whether they meet the selection criteria/exclusion criteria through visit evaluation, and then enter one of the test group and the control group according to the order in which appropriate human subjects are registered. Randomly assigned. Assigned subjects consume food for human application test (test food or control food) twice/day for 8 weeks. The purpose of this human application test is to prove that the test group (Psidium mushroom mycelium extract) is superior to the control group (Placebo) in increasing NK cell activity after 8 weeks of administration. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Others (It was planned to evaluate the efficacy and safety of enhancing immune function compared to the control food (Placebo) when ingesting Phellinus linteus(sanghuang) extract) |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator |
Allocation | RCT |
Intervention Type | Dietary Supplement |
Intervention Description | Test food: Phellinus linteus(sanghuang) extract (1,000 mg/day) Control food: placebo (dextrin 1,000 mg/day) Take orally for 8 weeks, twice a day, 1 capsule at a time. |
Number of Arms | 2 |
Arm 1 |
Arm Label Experimental group |
Target Number of Participant 49 |
|
Arm Type Experimental |
|
Arm Description Phellinus linteus(sanghuang) extract 1,000mg/day twice a day, once a capsule taken orally for 8 weeks |
|
Arm 2 |
Arm Label Control group |
Target Number of Participant 49 |
|
Arm Type Placebo comparator |
|
Arm Description Take the placebo formulation orally twice a day, one capsule at a time for 8 weeks |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (D50-D89)Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism (D84.9)Immunodeficiency, unspecified Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~65Year |
|
Description 1. Men and women aged 20 to 65 years old 2. Peripheral blood WBC of 3×1000/μl or more and less than 10×1000/μl 3. Those who have had upper respiratory tract infections or cold symptoms, a typical disease that can cause upper respiratory tract infections, more than two times within one year before the start of the test 4. A person who has agreed to participate in this test and signed a written consent form by the subject (or legal representative) voluntarily |
|
Exclusion Criteria |
1. Those who are currently being treated for clinically significant acute or chronic cardio-cerebrovascular system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal disease, psychotic, infectious and hematologic/neoplastic diseases, etc. You can participate in the research at the discretion of the research director considering the status of 2. Those with uncontrolled hypertension (160/100mmHg or more, measured after 10 minutes of rest for the subject) 3. Patients with uncontrolled diabetes (fasting glucose 126mg/dL or higher, or starting a new drug due to diabetes within 3 months) 4. Those whose AST(GOT) or ALT(GPT) blood level is 3 times or more than the normal upper limit of the relevant organ7,8,9 5. Creatinine blood levels exceeding 2.4mg/dL for men and 1.8mg/dL for women 6. Those who have consumed or are ingesting health functional foods that may affect immunity within 2 weeks before screening 7. Those who complain of severe gastrointestinal symptoms such as heartburn and indigestion 8. Pregnant, lactating or planning to become pregnant during the study period 9. Those who are sensitive or allergic to test food related foods 10. Those who plan to participate in other studies during this study 11. Those who received other study drugs within 4 weeks of starting this study 12. Those who the researcher deems unsuitable for this study |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | NK cell activity |
|
Timepoint | 0 weeks (before intake), 8 weeks |
|
Secondary Outcome(s) 1 | ||
Outcome | WBC |
|
Timepoint | 0 weeks (before intake), 8 weeks |
|
Secondary Outcome(s) 2 | ||
Outcome | IFN-γ |
|
Timepoint | 0 weeks (before intake), 8 weeks |
|
Secondary Outcome(s) 3 | ||
Outcome | IL-1β, IL-2, IL-6, IL-12 |
|
Timepoint | 0 weeks (before intake), 8 weeks |
|
Secondary Outcome(s) 4 | ||
Outcome | IgG1, IgG2, IgM |
|
Timepoint | 0 weeks (before intake), 8 weeks |
|
Secondary Outcome(s) 5 | ||
Outcome | TNF-α |
|
Timepoint | 0 weeks (before intake), 8 weeks |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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