FluGone™ - Clinical Trials

I Product Info I Ingredients
I Recommended Use
I Clinical Trials
I Research Brief
I References
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Indication: frequent common colds, decreased immune response, flu epidemic.

Main Actions: first aid against the common colds and inflammatory diseases, has antibacterial properties, strengthens the immune system, contains 5 different forms of vitamin C, minerals and herbal ingredients to enhance the body’s natural defenses.

Ingredients:(per 1 capsule):

vitamin C (as ascorbic acid, calcium ascorbate, ascorbyl palmitate, acerola (Malpighia glabra L) 4:1 fruit extract, rose hips (Rosa rugosa) powder – 175 mg, zinc (as zinc glycinate) – 3.75 mg, selenium (as Selenium+GPM™) – 17 mcg, Echinacea (Echinacea purpurea) 5:1 extract (whole plant)(4% polyphenolic compounds) (equivalent to 800 mg of crude herb) – 160 mg, odor controlled garlic (Allium sativum L.) (10,000 ppm allicin) – 125 mg.

 

FluGone™ - Clinical Trials:

Echinacea is safe and effective product. Echinacea purpurea extracts have been shown to stimulate the growth and activity of cells of the immune system (macrophages, natural killer cells, T-cells). Echinacea treatment results in a significant increase in an immune response to infection (assessed by immunoglobulin response). Echinacea can also increase production of interferon, an important part of the body’s response to viral infections.

Several double-blind studies have confirmed the benefit of Echinacea for treating colds and flu. (7,8,9,10,11)

 

A randomized, placebo-controlled, double-blind clinical trial was studying the effect of echinacea on the frequency and severity of cold and flu in a group of patients with high susceptibility to infections. 108 patients participated in a study, 54 of them received 2-4 ml of Echinacea juice per day, and the other 54 were receiving placebo. Compare with placebo group, the patients who received Echinacea became sick less frequently, with shorter duration and weaker symptoms.

The study demonstrated the effectiveness of Echinacea use for patients with compromised immune response. (12)

 

Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, AB, Canada.

The objective of this study was to test the efficacy of highly standardized echinacea formulation in reducing the severity and duration of symptoms of a naturally acquired common cold. METHODS: In a randomized, double-blind, placebo-controlled trial, 282 subjects aged 18-65 years with a history of two or more colds in the previous year, but otherwise in good health, were recruited. The subjects were randomized to receive either echinacea or placebo. They were instructed to start the echinacea or placebo at the onset of the first symptom related to a cold, consuming 10 doses the first day and four doses per day on subsequent days for 7 days. Severity of symptoms (10-point scale: 0, minimum; 9, maximum) and dosing were recorded daily. A nurse examined the subjects on the mornings of days 3 and 8 of their cold. RESULTS: A total of 128 subjects contracted a common cold (59 echinacea, 69 placebo). The total daily symptom scores were found to be 23.1% lower in the echinacea group than in placebo in those who followed all elements of the study protocol (P<0.01). Throughout the treatment period, the response rate to treatments was greater in the echinacea group. A few adverse event profiles were observed in both groups. CONCLUSIONS: Early intervention with a standardized formulation of echinacea resulted in reduced symptom severity in subjects with naturally acquired upper respiratory tract infection. Further studies with larger patient populations appear to be warranted. (13)

 

Garlic has a long history of use for treating or preventing colds.

One hundred forty-six volunteers were randomized to receive a placebo or an allicin-containing garlic supplement, one capsule daily, over a 12-week period between November and February. They used a five-point scale to assess their health and recorded any common cold infections and symptoms in a daily diary. The active-treatment group had significantly fewer colds than the placebo group (24 vs 65, P < .001). The placebo group, in contrast, recorded significantly more days challenged virally (366 vs 111, P < .05) and a significantly longer duration of symptoms (5.01 vs 1.52 days, P < .001). Consequently, volunteers in the active group were less likely to get a cold and recovered faster if infected. Volunteers taking placebo were much more likely to get more than one cold over the treatment period.

CONCLUSIONS: An allicin-containing supplement can prevent attack by the common cold virus. (14)

 

In test tube studies garlic has been found to have antibacterial, antiviral, and antifungal activity. (15)

 

Department of Public Health, University of Helsinki, Finland.

In three trials of subjects under heavy acute physical stress, common cold incidence decreased by on average 50%, and in four trials of British males common cold incidence decreased by on average 30% in the vitamin C groups.

The dietary vitamin C intake in the UK is low, and consequently the benefit may be due to the correction of marginal deficiency, rather than high vitamin doses.

Regular vitamin C supplementation (> or =1 g/day) has quite consistently reduced the duration of colds, but the size of the benefit has varied greatly. In the four largest studies the duration of colds was reduced only by 5%. In two of these studies, however, absence from school and work was reduced by 14-21% per episode, which may have practical importance.

Three controlled studies recorded a reduction of at least 80% in the incidence of pneumonia in the vitamin C group, and one randomised trial reported substantial treatment benefit from vitamin C in elderly UK patients hospitalized with pneumonia or bronchitis.

It seems that the preventive effects of supplementation are mainly limited to subjects with low dietary vitamin C intake, but therapeutic effects may occur in wider population groups. Further carefully designed trials are needed to explore the effects of vitamin C. (1)

 

Department of Public Health, University of Helsinki, Finland.

Several studies have observed an increased risk of respiratory infections in subjects doing heavy physical exercise. Vitamin C has been shown to affect some parts of the immune system, and accordingly it seems biologically conceivable that it could have effects on the increased incidence of respiratory infections caused by heavy physical stress.

In this report the results of three placebo-controlled studies that have examined the effect of vitamin C supplementation on common cold incidence in subjects under acute physical stress are analyzed.

In one study the subjects were school-children at a skiing camp in the Swiss Alps, in another they were military troops training in Northern Canada, and in the third they were participants in a 90 km running race. In each of the three studies a considerable reduction in common cold incidence in the group supplemented with vitamin C(0.6-1.0 g/day) was found. The pooled rate ratio (RR) of common cold infections in the studies was 0.50 (95% CI: 0.35-0.69) in favour of vitamin C groups.

Accordingly, the results of the three studies suggest that vitamin C supplementation may be beneficial for some of the subjects doing heavy exercise who have problems with frequent upper respiratory infections. (16)

 

School of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.

OBJECTIVE: To review the laboratory and clinical evidence of the medicinal value of zinc for the treatment of the common cold. DATA SOURCES: Published articles identified through Medline (1980-2003) using the search terms zinc, rhinovirus, and other pertinent subject headings. Additional sources were identified from the bibliographies of the retrieved articles. STUDY SELECTION: By the author. DATA EXTRACTION: By the author. DATA SYNTHESIS: Human rhinoviruses, by attaching to the nasal epithelium via the intracellular adhesion molecule-1 (ICAM-1) receptor, cause most colds. Ionic zinc, based on its electrical charge, also has an affinity for ICAM-1 receptor sites and may exert an antiviral effect by attaching to the ICAM-1 receptors in the rhinovirus structure and nasal epithelial cells.

In three trials with similar study designs, methodologies, and efficacy assessments, zinc effectively and significantly shortened the duration of the common cold when it was administered within 24 hours of the onset of symptoms.

Recent reports of trials with zinc gluconate administered as a nasal gel have supported these findings; in addition, they have shown that treatment with zinc nasal gel is effective in reducing the duration and severity of common cold symptoms in patients with established illness.

CONCLUSION: Clinical trial data support the value of zinc in reducing the duration and severity of symptoms of the common cold when administered within 24 hours of the onset of common cold symptoms. Additional clinical and laboratory evaluations are warranted to further define the role of ionic zinc for the prevention and treatment of the common cold and to elucidate the biochemical mechanisms through which zinc exerts its symptom-relieving effects. (17)