Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling Seniors

Last updated: July 6, 2011
Sponsor: Capital Health, Canada
Overall Status: Completed

Phase

3

Condition

Bronchitis

Covid-19

Respiratory Syncytial Virus (Rsv) Infection

Treatment

N/A

Clinical Study ID

NCT00240461
CVT-E002-2005-2
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study 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 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.

Eligibility Criteria

Inclusion

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

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 thelast 3 months with oral steroids - prednisone >10mg/day, other chronic respiratoryillness)

  • 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 witha dose <600 mg/day of vitamin E and containing no vitamin K) including echinacea orginseng-containing products (tea, capsules, extracts, tablets)

  • current alcohol/drug abuse

  • major surgery in the past 6 months

  • allergies to ginseng

Study Design

Total Participants: 780
Study Start date:
September 01, 2005
Estimated Completion Date:
December 31, 2008

Study 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 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.

Connect with a study center

  • Alberta Health Services

    Edmonton, Alberta T5M 3Z7
    Canada

    Site Not Available

  • UBC Gerontology and Diabetes Research

    Vancouver, British Columbia
    Canada

    Site Not Available

  • IWK Health Centre

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario
    Canada

    Site Not Available

  • Dr. Albert Osterhaus

    Rotterdam,
    Netherlands

    Site Not Available

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