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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.
The extract of Korean red ginseng has been found efficacious in the prevention of respiratory infections in healthy adults. The investigators will be conducted a randomized, double-blind, placebo-controlled study at the onset of the influenza season. A total of 100 subjects 30-70 years of age with a history of at least 2 colds in the previous year will be recruited from the general population in jeollabuk-do, South Korea. The subjects will be instructed to take 9 capsules per day of either the Korean red ginseng extract or a placebo for a period of 12weeks. The primary outcome measure will be the number of Jackson-verified colds. Secondary outcome measures will be included symptom severity, total number of days of symptoms and duration of all colds. Cold symptoms will be scored by subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KRG Extract | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Korean red ginseng | Dietary Supplement | Korean red ginseng(3.0g/day) for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of ILI(Influenza Like Illness) | Subjects received the open-ended questions about frequency of ILI onset during study period. The frequency of ILI onset was checked weekly via telephone. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Severity of All Colds | Subjects received the open-ended questions about symptom severity of all colds onset during study period. The symptom severity of all colds onset was checked weekly via telephone. Symptom severity of all colds (score 0-27) was measured during study period. The original index consists of 9 Questions(Fever, Rhinorrhea, Nasal congestion, Sore throat, Cough, Sputum, Dyspnea, Headache, Myalgia). Individual question response is assigned a score of between 0 (none) to 3 (severe) and summed to form a total score(summed) ranging from 0 (best) to 27 (worst). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Seop Lee, MD | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 560-822 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23255845 | Derived | Lee CS, Lee JH, Oh M, Choi KM, Jeong MR, Park JD, Kwon DY, Ha KC, Park EO, Lee N, Kim SY, Choi EK, Kim MG, Chae SW. Preventive effect of Korean red ginseng for acute respiratory illness: a randomized and double-blind clinical trial. J Korean Med Sci. 2012 Dec;27(12):1472-8. doi: 10.3346/jkms.2012.27.12.1472. Epub 2012 Dec 7. | |
| 22314101 |
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The criteria were an age from 30 to 70 years, have contracted at least 2 colds in the past year. Subjects were excluded if they had been vaccinated against influenza in the previous 6 months.
Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | KRG(Korean Red Ginseng) Extract | KRG Extract(3times/day, 9capsules/day, 3g/day) for 12weeks KRG Extract : KRG Extract was extracted at high temperatures (above 95℃) |
| FG001 | Placebo | Placebo(3times/day, 9capsules/day, 3g/day) for 12weeks Placebo : Amount and calorie of placebo are same with KRG Extract. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | KRG Extract | |
| BG001 | Placebo | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of ILI(Influenza Like Illness) | Subjects received the open-ended questions about frequency of ILI onset during study period. The frequency of ILI onset was checked weekly via telephone. | per protocol analysis | Posted | Number | participants | 12 weeks |
|
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Serious and/or other [non-serious] adverse events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KRG Extract |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chang-Seop Lee | Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | 82-63-276-8284 | lcsmd@jbnu.ac.kr |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
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| Placebo |
| Dietary Supplement |
Placebo (3.0g/day) for 12 weeks |
|
| 12 weeks |
| Total Number of Days of Symptoms and Duration of All Colds | Extract of Korean red ginseng intake did not significantly reduced total number of days of symptoms and duration of all colds | up to 12 weeks |
| Ha KC, Kim MG, Oh MR, Choi EK, Back HI, Kim SY, Park EO, Kwon DY, Yang HJ, Kim MJ, Kang HJ, Lee JH, Choi KM, Chae SW, Lee CS. A placebo-controlled trial of Korean red ginseng extract for preventing influenza-like illness in healthy adults. BMC Complement Altern Med. 2012 Feb 8;12:10. doi: 10.1186/1472-6882-12-10. |
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Symptom Severity of All Colds | Subjects received the open-ended questions about symptom severity of all colds onset during study period. The symptom severity of all colds onset was checked weekly via telephone. Symptom severity of all colds (score 0-27) was measured during study period. The original index consists of 9 Questions(Fever, Rhinorrhea, Nasal congestion, Sore throat, Cough, Sputum, Dyspnea, Headache, Myalgia). Individual question response is assigned a score of between 0 (none) to 3 (severe) and summed to form a total score(summed) ranging from 0 (best) to 27 (worst). | per protocol analysis | Posted | Mean | Standard Deviation | Scores on a scale | 12 weeks |
|
|
|
| Secondary | Total Number of Days of Symptoms and Duration of All Colds | Extract of Korean red ginseng intake did not significantly reduced total number of days of symptoms and duration of all colds | Not Posted | up to 12 weeks |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | 0 | 0 | 0 | 0 |
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