Trial Outcomes & Findings for Efficacy of an Extract of Concentrated Korean Red Ginseng for Preventing Upper Respiratory Tract Infections (NCT NCT01478009)

Results Overview

Subjects received the open-ended questions about frequency of ILI onset during study period. The frequency of ILI onset was checked weekly via telephone.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

100 participants

Primary outcome timeframe

12 weeks

Results posted on

2012-12-25

Participant Flow

Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.

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.

Participant milestones

Participant milestones
Measure	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℃)	Placebo Placebo(3times/day, 9capsules/day, 3g/day) for 12weeks Placebo : Amount and calorie of placebo are same with KRG Extract.
Overall Study STARTED	50	50
Overall Study COMPLETED	49	49
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of an Extract of Concentrated Korean Red Ginseng for Preventing Upper Respiratory Tract Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	KRG Extract n=50 Participants	Placebo n=50 Participants	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	45.5 years STANDARD_DEVIATION 8.1 • n=5 Participants	46.3 years STANDARD_DEVIATION 9.8 • n=7 Participants	45.9 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	34 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	16 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment Korea, Republic of	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

Subjects received the open-ended questions about frequency of ILI onset during study period. The frequency of ILI onset was checked weekly via telephone.

Outcome measures

Outcome measures
Measure	KRG Extract n=49 Participants Oral intake Korean red ginseng(3.0g/day) for 12weeks.	Placebo n=49 Participants Oral intake placebo(3.0g/day) for 12weeks
Frequency of ILI(Influenza Like Illness)	12 participants	22 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

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).

Outcome measures

Outcome measures
Measure	KRG Extract n=49 Participants Oral intake Korean red ginseng(3.0g/day) for 12weeks.	Placebo n=49 Participants Oral intake placebo(3.0g/day) for 12weeks
Symptom Severity of All Colds	9.5 Scores on a scale Standard Deviation 4.5	17.6 Scores on a scale Standard Deviation 23.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

KRG Extract

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Chang-Seop Lee

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Phone: 82-63-276-8284

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place