Healthy Subjects
Conditions
Brief 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTKorean red ginseng
Korean red ginseng(3.0g/day) for 12 weeks
DIETARY_SUPPLEMENTPlacebo
Placebo (3.0g/day) for 12 weeks
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of ILI(Influenza Like Illness) | 12 weeks | Subjects received the open-ended questions about frequency of ILI onset during study period. The frequency of ILI onset was checked weekly via telephone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Severity of All Colds | 12 weeks | 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). |
| Total Number of Days of Symptoms and Duration of All Colds | up to 12 weeks | Extract of Korean red ginseng intake did not significantly reduced total number of days of symptoms and duration of all colds |
Countries
South Korea
Participant flow
Recruitment details
Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| KRG Extract | 50 |
| Placebo | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Placebo | KRG Extract | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Age Continuous | 46.3 years STANDARD_DEVIATION 9.8 | 45.5 years STANDARD_DEVIATION 8.1 | 45.9 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment Korea, Republic of | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 34 Participants | 28 Participants | 62 Participants |
| Sex: Female, Male Male | 16 Participants | 22 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 12 weeks
Population: per protocol analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| KRG Extract | Frequency of ILI(Influenza Like Illness) | 12 participants |
| Placebo | Frequency of ILI(Influenza Like Illness) | 22 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).
Time frame: 12 weeks
Population: per protocol analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KRG Extract | Symptom Severity of All Colds | 9.5 Scores on a scale | Standard Deviation 4.5 |
| Placebo | Symptom Severity of All Colds | 17.6 Scores on a scale | Standard Deviation 23.1 |
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
Time frame: up to 12 weeks