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A 8 week, randomized, double-blind, Placebo-controlled clinical trial of CAEC(Canavalia gladiata Arctium lappa L.(root) Extract Complex) for the evaluation of efficacy and safety on immune function

Status Approved

First Submitted Date

2019/03/07
Registered Date

2019/03/25
Last Updated Date

2020/06/22

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003664
Unique Protocol ID	AKY_CAEC-2
Public/Brief Title	A 8 week, randomized, double-blind, Placebo-controlled clinical trial of CAEC(Canavalia gladiata Arctium lappa L.(root) Extract Complex) for the evaluation of efficacy and safety on immune function
Scientific Title	A 8 week, randomized, double-blind, Placebo-controlled clinical trial of CAEC(Canavalia gladiata Arctium lappa L.(root) Extract Complex) for the evaluation of efficacy and safety on immune function
Acronym	AKY_CAEC(Canavalia gladiata Arctium lappa L.(root) Extract Complex)-2
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

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	DJDSKH-19-DR-01
Approval Date	2019-02-08
Institutional Review Board Name	Daejeon University Dunsan Korean Medicine Hospital Institutional Review Board
Institutional Review Board Address	75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon
Institutional Review Board Telephone	042-470-9488
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	YangChun Park
Title	Ph.D
Telephone	+82-42-470-9126
Affiliation	Dunsan Korean Medicine Hospital of Daejeon University
Address	75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon
Contact Person for Public Queries
Name	YeeRan Lyu
Title	KMD
Telephone	+82-42-470-9663
Affiliation	Dunsan Korean Medicine Hospital of Daejeon University
Address	75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon
Contact Person for Updating Information
Name	YeeRan Lyu
Title	KMD
Telephone	+82-42-470-9663
Affiliation	Dunsan Korean Medicine Hospital of Daejeon University
Address	75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2019-03-28 Actual
Target Number of Participant	100
Primary Completion Date	2019-08-29 , Actual
Study Completion Date	2019-08-29 , Actual
Name of Study	Daejeon Korean Medicine Hospital of Daejeon University
Recruitment Status	Completed
Date of First Enrollment	2019-03-28 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	AEKYUNG Industry
Organization Type	Others
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	AEKYUNG Industry
Organization Type	Others

7. Study Summary

Study Summary Information
Lay Summary	This trial was designed to evaluate the efficacy and safety of CAEC compared to placebo in terms of immune function enhancement in adults with reduced immunity. The subject (or legal representative) will sign the consent form of the trial application after evaluating the inclusion and exclusion criterion, then randomly assigned to one of the interventino or control groups. The subject twill take application tablet or placebo once a day for 8 weeks.

Study Summary Information

Lay Summary

This trial was designed to evaluate the efficacy and safety of  CAEC compared to placebo in terms of immune function enhancement in adults with reduced immunity. The subject (or legal representative) will sign the consent form of the trial application after evaluating the inclusion and exclusion criterion, then randomly assigned to one of the interventino or control groups. The subject twill take application tablet or placebo once a day for 8 weeks.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Others
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator, Outcome Accessor
Allocation	RCT
Intervention Type	Dietary Supplement
Intervention Description	Experimental Products(extracted Canavalia gladiat complex) • Main Component: extracted Canavalia gladiat complex • Weight: 1000mg/tablet • Usage and Capacity: Intake 1 tablet/time and once a day Placebo Products • Main Component: crystalline cellulose • Weight: 1000mg/tablet • Usage and Capacity: Intake 1 tablet /time and once a day
Number of Arms	2
Arm 1	Arm Label placebo
	Target Number of Participant 50
	Arm Type Placebo comparator
	Arm Description • Main Component: crystalline cellulose • Weight: 1000mg/tablet • Usage and Capacity: Intake 1 tablet /time and once a day, 8 weeks
Arm 2	Arm Label CEAC(Canavalia gladiata arctium lappa leaf extract complex)
	Target Number of Participant 50
	Arm Type Experimental
	Arm Description • Main Component: extracted Canavalia gladiat complex • Weight: 1000mg/tablet • Usage and Capacity: Intake 1 tablet/time and once a day, 8 weeks

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (J00-J99)Diseases of the respiratory system (J98.48)Other disorders of lung Immunocompromized adults
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 25Year~75Year
	Description 1) Male or female subjects aged from 25 to 75 years old. 2) Screening white blood cell(WBC) ranged from 3000 to 8000 cells/ul. 3) Stress self assessment scaled above "strong"(4 scales: none, moderate, strong, intense) 4) Subjects suffered from upper respiratory track infection or cold-related symptoms which have possibilities to cause upper respiratory track infection more than two times in the past one year. (*Tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc.) 5) Subjects who agreed to participate in this study and subjects(or legal representative) who signed written informed consent voluntarily.
Exclusion Criteria	1) history or presence of clinically significant acute or chronic cardiovascular, immune, respiratory, liver, biliary, renal, and urological system, nervous system, musculoskeletal disease, psychological, infectious, and hematologic / teratogenic diseases.(possible to participate judged by the investigators considering the condition of the subject) 2) uncontrolled hypertension (above 160 / 100mmHg, after 10 minutes of rest) 3) diabetes (FBS(fasting blood sugar) level greater than 126 mg/dl or taking drugs due to diabetes) 4) vaccinated within 3 months before screening 5) AST(aspartate aminotransferase) or ALT(alanine aminotransferase) is more than three times the normal upper limit 6) Creatinine blood level is above normal level 7) ingested dietary supplements that can affect immune status within 2 weeks before screening 8) complain of severe gastrointestinal symptoms such as heartburn, indigestion, etc. 9) Body Mass Index (BMI) of 25 kg/m2 or more 10) pregnant, breastfeeding or who have a pregnancy plan during this trial 11) plan to participate other trial during this trial 12) participated in other trial within 8 weeks of the start of this trial 13) judged by the investigators to be inappropriate for the clinical trial 14) sensitive or allergic to food for trial application
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	NK cell(natural killer cell) activity
Timepoint	week 0, week 4, week 8
Secondary Outcome(s) 1
Outcome	Interferon-γ
Timepoint	week 0, week 4, week 8
Secondary Outcome(s) 2
Outcome	Interleukin-2, Interleukin-10, Interleukin-12
Timepoint	week 0, week 4, week 8
Secondary Outcome(s) 3
Outcome	White Blood Cell count
Timepoint	screening, week 4, week 8
Secondary Outcome(s) 4
Outcome	saliva immunoglobulin A, Cortisol
Timepoint	week 0, week 8
Secondary Outcome(s) 5
Outcome	T cell, B cell, NK cell(natural killer cell) population
Timepoint	week 0, week 4, week 8
Secondary Outcome(s) 6
Outcome	self evaluaion of improvement
Timepoint	week 4, week 8
Secondary Outcome(s) 7
Outcome	frequency of common cold
Timepoint	week 4, week 8
Secondary Outcome(s) 8
Outcome	phagocytosis
Timepoint	week 0, week 4, week 8

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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