Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling Seniors
Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling Seniors
Seniors are a population vulnerable to respiratory infections. It is hypothesized that
 regular use of COLD-fX following an influenza vaccination would potentially augment immune
 response in the elderly. Use of COLD-fX may also provide additional protection again
 respiratory infection and reduce the incidence and severity of respiratory infections in
 otherwise healthy seniors.
Eligible seniors will be randomly placed into three groups to receive 400 mg/day, 800mg/day
 or a placebo for a period of six months beginning in October. Daily dosing will be recorded
 as well as any symptoms not related to having a respiratory infection. For seniors who
 experience a respiratory infection, they are asked to call a study nurse who will take a
 nasopharyngeal swab. The seniors are also asked to record on a diary card the severity of
 their symptoms on a scale from 0-3 (none, mild, moderate, severe). Symptoms include cough,
 fever, runny nose, stuff nose, aches and pains, headache, chills, sneezing, ear aches and
 fatigue.The swab will be taken to the lab for testing for upper respiratory viruses.
Inclusion Criteria:

 -  Age 65 years of age and older

 -  current season influenza immunization

 -  available for follow-up visits

 -  willing and able to sign written informed consent

 Exclusion Criteria:

 -  HIV infection

 -  malignancy (under active observation or treatment)

 -  unstable cardiovascular diseases

 -  renal abnormalities (serum creatine >200umol/l)

 -  pulmonary disease (chronic bronchitis, emphysema, or asthma requiring treatment in the
 last 3 months with oral steroids - prednisone >10mg/day, other chronic respiratory
 illness)

 -  acute or active chronic liver disease

 -  neurologic or psychiatric disease (progressive or currently under treatment

 -  active tuberculosis

 -  multiple sclerosis

 -  bleeding disorders

 -  planned surgery over the course of the trial

 -  on immunosuppressive therapy

 -  taking oral steroids at dose = to prednisone 10 mg/day or more

 -  taking phenelzine, pentobarbital, haloperidol, warfarin, heparin

 -  use of natural health products(except the study product and vitamins and minerals with
 a dose <600 mg/day of vitamin E and containing no vitamin K) including echinacea or
 ginseng-containing products (tea, capsules, extracts, tablets)

 -  current alcohol/drug abuse

 -  major surgery in the past 6 months

 -  allergies to ginseng