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The common cold is a viral disease that affects the upper respiratory system while influenza is an infectious respiratory tract infection that can be caused by any one of the three influenza viruses, namely A, B, and C. Viruses gain entry into the body through the respiratory tract and attach to the cells that line the nasal cavity, throat, and bronchial tubes. Inside the cells, the viruses take over cell activities causing the production of many similar viral particles. The body responds to the viral invasion by organizing its defenses. Therefore, the nose and throat, for instance, release chemicals, which trigger the immune system. The injured cells produce prostaglandins that cause inflammation and attract white blood cells that fight infection. The immuno-stimulant property of Echinacea allows it to be used as a natural product against flu and common cold with Echinacea purpurea being the most widely used product. The purpose of this study will be to determine the effect of Echinacea on the common cold and flu-like symptoms. The variables will be analyzed individually using a chi-square with a 99.95% confidence level. Statistical analyses will be performed using the SAS system. The study will bridge the existing gap between those who believe that the plant help in preventing or treatment of cold and those who believe that the plant does not prevent or treat common cold and flu symptoms.

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Introduction

Echinacea, also known as American Cone Flower, Black Sampson, Black Susans, Brauneria Angustifolia, Brauneria Paallda, Comb Flower, or Coneflower is a herb that is native to the rocky mountains of the United States, Canada, and Europe. There are several species of the Echinacea plant whose leaves, flowers, or roots are used for medicinal purposes. Traditionally, Echinacea was used for herbal remedies by the tribes that lived in the great plains of India. Later on, the settlers followed the Indian examples where they began using the plant for medicinal reasons as well. Echinacea was even listed in the United State’s Formulatory, but its use decreased when antibiotics were discovered. However, people are again becoming more interested in the plant, because some of the antibiotics no longer work well against certain infections.

Besides, Echinacea has been widely used to fight infections, particularly, the common cold, flu, as well as other upper respiratory infections. There are people who take Echinacea whenever they experience the first sign of cold, with the hope that they would stop the cold from developing. Similarly, there are other people who take Echinacea when cold symptoms have started to manifest with the hope that the symptoms would not be very severe. Commercially available Echinacea products come in the form of tablets, tea, and juice. Nonetheless, there have been concerns regarding the quality of some of the products because of mislabeling while others do not even contain the extracts from the plant, in spite of the label assertions. Echinacea works by activating chemicals in the body that reduce inflammation, thus, may reduce flu and cold symptoms.

Most people believe that there is no cure for common cold because of many different viral strains that can cause characteristic symptoms such as cough, runny nose, sneezing, or sore throat (Centers for Disease Control and Prevention, 2016). Even though most people with cold symptoms may have rhinovirus strains, it can be more prevalent during certain seasons. Colds are caused by viruses, thus, antibiotics are always ineffective against them. Moreover, antiviral medications are yet to be more sophisticated to effectively cure many of the conditions caused by viruses. Rather than treating the condition, most of the existing cold remedies treat the symptoms. As a consequence, people are turning to natural remedies in order to prevent, soothe, or even shorten cold duration. Even though there are natural cold treatment options that are supported by research, natural products that do not have adequate scientific backing may require comprehensive evaluation before use. For instance, it is appropriate to examine the advantages and disadvantages, all the risks, benefits and any evidentiary support before use. Therefore, this research will evaluate the effect of Echinacea on common cold and flu-like symptoms based on existing information.

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Disease Background and Use of Echinacea

The common cold also known as acute rhinopharyngitis, nasopharyngitis, acute coryza, or a cold is a viral infectious disease that affects the upper respiratory system, due to corona viruses and rhinoviruses. On the other hand, influenza is a respiratory tract infection that can be caused by A, B or C influenza viruses. It is important to note that influenza C spreads mild infections in young children and infants that confers life-long immunity, while in adults, infection from influenza C are rarely reported and often asymptomatic (Kalra, Khatak, & Khatak, 2011). In contrast, influenza viruses A and B affect all age groups and cause seasonal epidemics.

Viruses gain entry into the body through the respiratory tract, and then attach to the cells that line the nose, throat, and bronchial tubes. When people are exposed to cold, wind, damp or even rapid changes in temperature, they become more predisposed. Thereafter, pathogens enter the throat and nose layers, particularly, when cold weather come and adhere to the cells. Once the viruses have attached to the cells, they punch holes in the cell membrane so that genetic materials can easily gain entry to the cells (Kalra et al., 2011).

Inside the cells, the viruses take over cell activities thereby resulting in the cells producing many similar viral particles. To respond to the viral invasion, the body often organizes its defenses. Therefore, the nose and throat, for instance, release chemicals, which trigger the immune system, and the injured cells produce prostaglandins that cause inflammation and attract white blood cells that fight infection. Tiny blood cells stretch in the process, thereby, creating a space that is filled by plasma and specialized white cells, particularly, the infected areas. Body temperature rises consequently, and the immune response is enhanced (Kalra et al., 2011).

The release of histamine helps to increase the production of nasal mucus that not only traps viral particles but also helps in their removal from the body. The increased battle against the cold virus results in the release of lymphocytes and monocytes for counterattacks. There is also the interferon that acts as the body’s own antiviral drug and more than 20 proteins that coat viruses, as well as infected cells, are creating a way for the white blood cells to recognize and destroy the pathogens. The symptoms that manifest as cold are basically the body’s natural immune response (Kalra et al., 2011). On the one hand, colds are characterized by nasal congestion, sore throat, and cough, often without fever. On the other hand, flu manifests more suddenly and is accompanied by sore muscles, fever, cough, and fatigue. The ailments can take from a few days up to a week; however, they can progress to strep throat, bronchitis, or asthma, where there is no proper treatment. Fever causes heating up of the body and infection destruction. Simple physical measures, such as frequent hand washing, wearing gloves, and masks can be efficient in preventing the spread of respiratory viruses. Likewise, conventional therapy has been used in the management of flu and cold. Conventional therapy usually involves the treatment of symptoms (Kalra et al., 2011).

There are also herbal treatments (Raal, Volmer, Sukand, Hratkeviti, & Kalle, 2013). Scientists have for a long time pursued the chemical world within plants to discover their incredible healing secrets. The numerous investigations have led to the discovery of natural compounds that have promising medical and health potential. Most of the drugs that are used today have active ingredients, which were derived from ancient plants (Raal et al., 2013). The botanicals that are used in the treatment of flu and cold are classified according to their mechanisms of action. Among the mechanisms include diaphoretic, febrifuge, antiseptic, expectorant as well as immune-stimulant (Kalra et al., 2011).

Notably, the immune-stimulant category, where Echinacea belongs, includes plants with active ingredients that increase antibody production, stimulate activity of major white blood cells and raise white blood cell counts. Immuno-stimulants have polysaccharides and proteins that stimulate the work of immune system (Kalra et al., 2011). The immuno-stimulant property of Echinacea is responsible for its role in the fight against flu and common cold. Echinacea purpurea remains the most widely used natural product in the prevention and treatment of common cold. The plant has alkaloids, alkylamide, as well as polyacetylene fragments believed to stimulate leukocytes and increase the release of interleukin and TNF (Henriquez, Hayney, Xie, Zhang, & Barrett, 2015). If treatment using Echinacea is started within 24 hours of disease onset, then the duration of infection can be shortened, but the severity of symptoms may not reduce. Fresh juice pressed from the flowers of E. purpurea combined with alcohol as well as tinctures of root of E. pallida reduce common cold symptoms. Also, root tinctures of E. Angustifolia reduce symptoms of the common cold (Kalra et al., 2011).

PICOT Question

The PICOT question that will be utilized as the basis for this search is: in college students aged at least 18 years (P), does the use of Echinacea (I) compared to non-use of Echinacea (C) result in prevention and treatment of common cold and flu-like symptoms within 2 months (T)? The PICOT question is appropriately presented. Therefore, it will be easy to conduct the necessary search. Specifically, there is a target population for this study. Also, there is a proposed intervention and a control group. Finally, the outcome is expected to be determined within a specific time period after the implementation of intervention therapy.

The peer-reviewed protocol will be utilized to get articles on Echinacea, common cold and flu treatment to lay the foundation for this study. Specifically, the meSH strategy will be utilized because it is a two-staged process (U.S. National Library of Medicine, 2015). The first stage will involve identification of eligible studies within a given period; in this case, articles from 2011 to 2016 will be used. The process will involve the selection of the most accurate and appropriate search terms from the foundational articles. The second process will involve conducting search and retrieving evidence from medical journals using preset Boolean connectors and meSH search terms (U.S. National Library of Medicine, 2015). Supporting literature will be sought from CINAHL, Medline, and Cochrane Review.

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Hypothesis

1. (a). In college students, using Echinacea results in the prevention and treatment of common cold and flu-like symptoms within 2 months.

(b). In college students, using Echinacea results in the prevention and treatment of common cold and flu-like symptoms within 2 months.

Statement of the Problem

Previous clinical studies on the effect of Echinacea on common cold and flu symptoms have had mixed results. Some studies have recorded statistically significant benefits or trends towards such benefits. There are also manufacturer-sponsored studies that have reported moderate to poor quality of the drugs on the symptoms.

Purpose of the Study

This study will be seeking to determine the effect of Echinacea on the common cold and flu-like symptoms as a way of bridging the existing gap between those who believe that the plant helps in preventing or treatment of cold and those who believe that the plant does not prevent or treat the common cold and flu-like symptoms.

Research Question/Hypothesis

In college students, does the use of Echinacea, as compared to non-use of Echinacea result in the prevention and treatment of common cold and flu-like symptoms within just 1 month?

Methodology

Research Design

This study will be a randomized controlled clinical study that will be conducted at the university. The conduct of the study will be according to the Helsinki declaration of 2000, the International Conference on Harmonization (ICH) guidelines, and good clinical practice (GCP) requirements. Furthermore, the study will seek ethical approval from the university. Starting from September to November 2016, healthy participants will be included in the study. The participants will receive E. purpurea extract. During the inclusion visit, each of the participants will be given a medication that will last for a period of one month and a diary for recording adverse reactions, as well as the severity of cold and flu symptoms. At the end of the month, each of the participants will be required to return the completed diaries and any unused medications. After determining the compliance, as well as the completion of the returned diary, patients will be given new diaries to complete for one more month.

The Echinacea product that will be used in this study is commercially available in drops and is a product of A. Vogel Bioforce from Switzerland. The product is microbiologically tested and does not contain endotoxins. The liquids will be aliquoted into bottles with screw caps and calibrated syringes will be provided to ensure adequate dosing. The therapy will be provided according to the manufacturer’s recommendations, and participants will be swallowed each day to prevent illnesses. Every dose is expected to be diluted using water and will remain in a patient’s mouth for approximately 15 seconds; a strategy is aimed at ensuring maximum antiviral effects. To assess compliance, returned bottles will be weighed during the monthly visits. Similarly, to ensure that the participants have adhered to the prescribed dosing, calculations for acute and total prophylactic dosing will be detailed in the provided diaries. This method of administration is considered because it not only reflects the conventional use of E. purpurea, but also ensures accurate dosing.

Participants for this study will be recruited through advertisements that will be made in the university. Respondents will initially receive information leaflets that describe the study. To be included in the study, individuals will have to be aged 18 years or more and be in good physical condition. The individuals to be included in the study will be those that have experienced flu and common cold episodes more than twice a year. They will be those that are enrolled in another study, pregnant and breastfeeding women, those taking antiviral or antibacterial medication, those with known autoimmune diseases, diabetic patients, asthmatic patients receiving corticosteroid therapy, and individuals with known allergy to plant products. Likewise, volunteers who have known laboratory abnormalities will be dropped from inclusion. All participants will be provided with consent forms to sign. In the forms, the participants will find explanations regarding the objectives. They will sign the consent forms as an indication that they are willing to take part in the study. Besides, the participants will be informed that they could withdraw from the study at any stage if they felt that they are being violated in any way.

This study will include 517 participants. The selection of participants will be random and each one will receive a unique treatment code for identification. The randomization code will be prepared using the RANCODE program. As a consequence, each participant will receive treatment according to the identification number received at the time of allocation during inclusion. The investigator will personally or through authorized personnel dispense the drugs. The randomization codes will be retained and kept in a sealed envelope and be opened only in case of an emergency. Using the codes instead of real names will help to protect the participants’ identity.

During the entire study duration, all participants will retain their diaries, where they will record answers to the question of whether they had experienced unexpected or unusual symptoms. Furthermore, during the monthly visits, the participants will be questioned about the events that they will have experienced by the study investigator. The adverse effects analyses will include all adverse effects, date and time of onset, and the days that the adverse effects will last after the application of the medication.

Statistical Model

All of the adverse effects will be coded using lowest level terms based on MedDRA Dictionary’s latest version. The lowest terms will be chosen to match the investigator’s description and then be translated into what is known as preferred terms. The participants will have in their diaries a question that asks whether they had a cold, and they will be expected to answer either ‘Yes’ or ‘No’. Afterward, the symptoms and symptoms to be evaluated will be headache, discharge from the nose, obstruction of the nose, sneezing, aching throat, and cough. The responses will be rated on a likert scale with entries ranging from 0 to 3, where 0 will mean absence, while 1, 2, 3 will be signifying mild, moderate and severe symptoms in the following order. Importantly, the diaries will have the description of various viral common cold and flu symptoms. A set of predetermined variables, including the number of cold episodes, the number of days that the episodes last and comedication will be analyzed. The parameters will be analyzed individually using a chi-square to determine how the cumulated events in the proposed treatment can be compared. The chi-square will have a 99.95% confidence level. Statistical analyses will be performed using the SAS system.

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Discussion

Prevention of diseases, such as common cold, is considered to have effects ranging from mild to moderate, which requires therapies that have satisfactory efficacy and safety profiles. For instance, common cold and flu require treatments that are preventive, because of their high frequency, as well as high costs that are incurred in treating the conditions. In spite of the prevalence of conditions, as well as significant research conducted in the past, there have not been conclusive preventive and treatment developed until today, particularly treatments whose safety profiles can be tolerated over a long period. This study will examine efficacy and safety variables using a highly sensitive method for detection.

The result of the study will be used to highlight safety concerns for Echinacea when used in the prevention and treatment of flu-like symptoms in a large population. Through the assessment of flu and cold episodes, using a highly accepted method, it will be possible to highlight preventive efficacy using a sufficient power. Importantly, this study will be used to determine if Echinacea has a strong antiviral effect on membranous viruses based on the ability of medication to reduce infection. The results of the current study will be compared with those of previous studies to determine consistencies and inconsistencies, particularly in the studies that have used similar preparations, as the one proposed in this study (Jawad, Schoop, Suter, Klein, & Eccles, 2012).

Budget

The budget for this research will entail the purchase of the Echinacea product known as A. Vogel Bioforce, the purchase of diaries, putting the advertisements, and developing the consent forms. The other costs will be for the purchase of the capped bottles for holding the product and syringes. It is estimated that the approximate cost of the project will be $ 28,400. This cost will be less compared to the amounts that patients spend yearly in the treatment of common cold and flu infections.

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Conclusion

The proposed study will help in determining the efficacy and safety of Echinacea as an alternative therapy in the treatment of flu and common cold symptoms. This two months of study will be very important in a number of ways. Firstly, it will be used to learn about the safety profile of Echinacea and whether it poses health risk. Secondly, the study will be used to determine the level of benefit that can be derived from using Echinacea for a prolonged period during treatment. From the risk and benefit results of this study, it will be possible to recommend or not recommend Echinacea for long-term prevention and treatment of common cold and flu infections. The rigor with which this study will be conducted will ensure validity and reliability of the outcome.