Phase 3
N=100
Efficacy of an Extract of Concentrated Korean Red Ginseng for Preventing Upper Respiratory Tract Infections
Healthy Subjects
Bottom Line
View on ClinicalTrials.gov: NCT01478009 ↗Enrolled (actual)
100
Serious AEs
—
Results posted
Dec 2012
Primary outcome: Primary: Frequency of ILI(Influenza Like Illness) — 12; 22 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Korean red ginseng (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Chonbuk National University Hospital
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of ILI(Influenza Like Illness) |
12; 22 | — |
| SECONDARY Symptom Severity of All Colds |
9.5; 17.6 | — |
| SECONDARY Total Number of Days of Symptoms and Duration of All Colds |
— | — |
Summary
Upper respiratory tract infections are a major source of morbidity throughout the world. Extracts of Korean red ginseng have been found to have the potential to modulate both natural and acquired immune responses. The investigators sought to examine the efficacy of an extract of Korean red ginseng in preventing colds. Therefore, the efficacy and safety of Korean red ginseng will be investigated in healthy subjects during the influenza season.
Eligibility Criteria
Inclusion Criteria
- Males and females 30-70 years old
- have contracted at least 2 colds in the past year
Exclusion Criteria
- if they had been vaccinated against influenza in the previous 6 months.
- Subjects with medical conditions such as multiple sclerosis, tuberculosis, diabetes, cancer, lupus, HIV/AIDS, cardiovascular disease, hypertension, neurologic or psychiatric disease, and renal, pulmonary and hepatic abnormalities
- Subjects taking medications such as immunosuppressive drugs, corticosteroids, warfarin, phenalzine, pentobarbital, haloperidol or cyclosporine
- Abnormal liver or kidney function tests (ALT or AST>2 times the upper limit of normal; elevated creatinine, males>125uM/L, females>110uM/L)
- pregnant or lactating women and heavy smokers.
- being judged by the responsible physician of the local study center as unfit to participate in the study
Data sourced from ClinicalTrials.gov (NCT01478009). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.