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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

780 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Immune Enhancing Effects of Acute Dosing of COLD-fX in Healthy Adults

NCT00435968

Healthy

COMPLETED PHASE2

Adjuvanted Influenza Vaccine Effectiveness in the Elderly (65+Yrs)

NCT01424371

Influenza

UNKNOWN

Comparison of 4 Influenza Vaccines in Seniors

NCT01368796

Influenza Vaccine

COMPLETED PHASE4

Safety and Protective Efficacy of FF-3 Dry Powder in Healthy Subjects Infected With Influenza Challenge Strain

NCT02423577

Influenza

COMPLETED PHASE2

Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly

NCT03695432

Influenza-like Illness

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Tract Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

200 mg COLD-fX Natural health products 2 times daily for six months

Group Type ACTIVE_COMPARATOR

COLD-fX natural health product

Intervention Type DIETARY_SUPPLEMENT

200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months

Arm 2

Arm 2 - 400 mg COLD FX Natural health product - 2 times daily for 6 months

Group Type ACTIVE_COMPARATOR

COLD-fX

Intervention Type DIETARY_SUPPLEMENT

400 mg COLD-fX natural health product 2 times daily for 6 months

3

Inactive crystalline substance. This is the placebo arm in which subject receive 200 mg of the placebo 2 times daily for 6 months. Placebo is an inactive crystalline substance.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

crystalline substance 200 mg twice daily for 6 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

COLD-fX natural health product

200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months

Intervention Type DIETARY_SUPPLEMENT

COLD-fX

400 mg COLD-fX natural health product 2 times daily for 6 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

crystalline substance 200 mg twice daily for 6 months

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Natural health product dietary supplement naural health products dietary supplements none available

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes