Status:
COMPLETED
Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling Seniors
Lead Sponsor:
Capital Health, Canada
Collaborating Sponsors:
Afexa Life Sciences Inc
IWK Health Centre
Conditions:
Respiratory Tract Infection
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
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 elderl...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
780 Patients enrolled
Trial Details
Trial ID
NCT00240461
Start Date
September 1 2005
End Date
December 1 2008
Last Update
July 7 2011
Active Locations (5)
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1
Alberta Health Services
Edmonton, Alberta, Canada, T5M 3Z7
2
UBC Gerontology and Diabetes Research
Vancouver, British Columbia, Canada
3
IWK Health Centre
Halifax, Nova Scotia, Canada
4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada