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12 weeks, single-center, randomized, double-blind, parallel design, placebo-controlled human study to assess the efficacy and safety of Cordyceps militaris Extract on Prevention of Upper Respiratory Tract Infection on healthy people

12 weeks, single-center, randomized, double-blind, parallel design, placebo-controlled human study to assess the efficacy and safety of Cordyceps militaris Extract on Prevention of Upper Respiratory Tract Infection on healthy people

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0000884
Enrollment
100
Registered
2013-10-15
Start date
2013-09-26
Completion date
Unknown
Last updated
2019-03-11

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 group: The main ingredient is Cordyceps militaris Extract, 2 times/day, 2 tablets/time. Placebo group: The main ingredient is crystaling Cellulose and lactose, 2 tim

Sponsors

Dong-A ST
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults aged 20~70 who had suffered more than twice Upper respiratory infection* disorder or common cold causing URI (*(tonsillitis), (pharyngitis), (laryngitis), (sinusitis), (otitis media), (rhinitis)) 2) People who sign the informed consent form before participating in the study

Exclusion criteria

Exclusion criteria: 1) subjects vaccinated against influenza within the last 6 months prior to the study 2) subjects with clinically significant cardiovascular, immune, infectious, or neoplastic disease currently 3) subjects who are under treatment for uncontrolled hypertension, diabetes, thyroid disease etc. (However, subjects can participate in the study based on doctor’s assessment) 4) subjects with Upper respiratory infection at screening visit 5) subjects who have taken medications such as immunosuppressive drugs, corticosteroids within the last 1 months 6) subjects with Allergic or hypersensitive to Cordyceps militaris 7) subjects with mental illness such as depression, schizophrenia, alcoholism, drug addiction 8) subjects whose creatinine level is twice higher than the upper limit 9) subjects whose AST(GOT) or ALT(GPT) level is twice higher than the upper limit 10) subjects with gastrointestinal tract disorder such as heartburn, dyspepsia 11) subjects who have taken functional foods within the last 2 weeks or is taking now for immune health 12) subjects who are pregnant, breast feeding or do not agree to use adequate contraception during this study period (except for surgery for female infertility) 13) subjects who have participated in another study within the last 2 months or scheduled for another study during this study period 14) Inappropriate subject decided by investigator

Design outcomes

Primary

MeasureTime frame
The frequency of URI onset

Secondary

MeasureTime frame
severity and duration of URI symptoms;frequency of URI onset at each visit;subjective assessment ;NK cell activity, IFN-?, IL-2, IgA

Countries

Korea, Republic of

Contacts

Public ContactOh mi-ra

Chonbuk National University Hospital

Outcome results

None listed

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