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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

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
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003664
Enrollment
100
Registered
2019-03-25
Start date
2019-03-28
Completion date
Unknown
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : *Experimental Products(extracted Canavalia gladiat complex) • Main Component: extracted Canavalia gladiat complex • Weight: 1000mg/tablet • Usage and Capacity: Intake 1 tablet/

Sponsors

AEKYUNG Industry
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

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

Design outcomes

Primary

MeasureTime frame
NK cell(natural killer cell) activity

Secondary

MeasureTime frame
Interferon-?;Interleukin-2, Interleukin-10, Interleukin-12;White Blood Cell count;saliva immunoglobulin A, Cortisol;T cell, B cell, NK cell(natural killer cell) population;self evaluaion of improvement;frequency of common cold;phagocytosis

Countries

Korea, Republic of

Contacts

Public ContactYeeRan Lyu

Dunsan Korean Medicine Hospital of Daejeon University

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026