250 mg E. purpurea root and 83 mg E.angustifolia root standardized to 10 mg alkylamides, and 210 mg of a proprietary synergistic extract blend containing andrographis paniculata leaf, black elderberry berries, sambucus nigra, ginger root, and zingiber officinale

Placebo will contain the excipients vegetable glycerin and olive oil. Placebo and echinacea capsules will be colored green and contain the same proportions of inert ingredients.

Acute Respiratory Infections

Quick Defense

Placebo

ASU-NCRC Human Performance Lab

Echinacea and Acute Respiratory Illness

Efficacy of Ingesting Gaia Herb's Quick Defense Product in Reducing Acute Respiratory Illness Symptomatology in Women: a 12-Week, Double Blind, Placebo-Controlled Randomized Trial

The Wisconsin Upper Respiratory Symptom Survey (WURSS-24) will be used to assess common cold illness severity and symptoms (see attached questionnaire). Subjects will fill in the one-page WURSS-24 at the end of each day during the 12-week monitoring period. This 12-week period will cover the winter and early spring period of 2014. From the responses recorded during the 84-day study, an ARI severity score will be calculated by summing the daily ARI global severity score (0=not sick, 1=very mild ARI to 7=severe). The ARI symptom score for the 84-day period will be calculated by summing all 10 symptom scores for each day's entry (0=do not have this symptom, 1=very mild to 7=severe). In similar fashion, the ARI function ability score for the 84-day period will be calculated by summing all 9 function scores for each day's entry (0=do not have this symptom, 1=very mild to 7=severe). Separate scores will be calculated comparing groups for each illness episode recorded by the subjects.

Appalachian State University

Gaia Herbs Inc.

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

Mindfulness Meditation

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Exercise

Wait-list Control

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

The primary outcome will be severity-weighted total cumulative days of ARI illness (global severity), calculated as trapezoidal approximation to area under the time severity curve during ARI illness, with severity assessed once daily using self-reports on the validated Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Incidence (number of ARI episodes in each group) and duration (total number of days of ARI illness) are components of the primary outcome, and will be analyzed separately.

Severity-weighted Total Days of ARI Illness

Employment, including type of work, hours per week worked, and compensation, assessed as hourly wage, will be assessed at enrollment. Each week throughout the study participants will complete questions to assess number of hours of work missed. Study personnel blinded to allocation group status will assess and classify reasons for missed work as either ARI-related or not ARI-related. Presented as a total cumulative number of days missed of work due to an ARI-related event.

Absenteeism

Cumulative total number of health care visits, ARI-related health care visits, and ARI-related prescriptions, including antibiotics and anti-influenza anti-virals will be documented. Each weekly communication will include the question, "Have you seen a doctor or visited a clinic, hospital or urgent care center?" Persons answering "Yes" will be asked the reason for the visit. Those answers will then be classified by blinded study personnel as either "Related," or "Unrelated" to ARI illness, including upper respiratory infection, influenza, pharyngitis, acute sinusitis, bronchitis, and pneumonia.

Health Care Utilization

Also known as the Medical Outcomes Study Short Form, this 12-item questionnaire is commonly used to measure overall health, including physical (SF12-P) and mental health (SF12-M) subscales. It has been extensively assessed for reliability, responsiveness and criterion validity. In this study, it will be used to assess potential changes in general physical and mental health due to interventions, and as a covariate to control for baseline between-person differences in multivariate efficacy analyses. Physical and Mental Health Composite Scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

SF-12

The PSS-10 has been validated in multiple studies. PSS scores predict rates of viral infection among volunteers inoculated with rhinovirus, and correlate with physiologic and self-report indicators of ARI illness, including nasal IL-6 level. Because stress reduction is one of the hypothesized mechanisms of action, this study population will include working-age participants, who are presumed to be more stressed. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Scores ranging from 0-13 would be considered low stress.
Scores ranging from 14-26 would be considered moderate stress.
Scores ranging from 27-40 would be considered high perceived stress.

Perceived Stress Scale (PSS-10)

The MSES is one of the more recent questionnaires, developed by Cayoun and Freestun to assess effects of MBSR training on perceived self-efficacy. The MSES assesses 7 domains related to mindfulness self-efficacy, including behavior, cognition, interoception, affect, interpersonal, avoidance and mindfulness. The MSES will provide a nice counterpart to the ESES to help distinguish effects of interventions on ARI outcomes. The lower the score, the lower self-efficacy is in using mindfulness skills.
The current lack of psychometric data for the MSES renders the following ranges very tentative. They are currently only a rough clinical guide and scores must be interpreted with caution.
0-34 Poor sense of self-efficacy 35-69 Weak sense of self-efficacy 70-104 Moderate sense of self-efficacy 105-140 Good sense of self-efficacy

Mindfulness-based Self Efficacy Scale (MSES)

Self-efficacy has been defined as "the belief in one's capabilities to organize and execute the courses of action required to manage prospective situations." The ESES scale was developed based on work by Bandura and colleagues,and has been validated by Shin, Kroll,and Everett. For this study, the ESES will be used to verify results of the exercise intervention, and to help explain potential mediational effects of exercise. The total score is derived by summing the scores for the individual items; possible scores range from 0 to 180. Total score (out of 180) is sum of item scores. Higher score represents greater perceived self efficacy.

Exercise Self-Efficacy Scale (ESES)

Sleep quality has been linked to several important quality of life and health outcomes. The PSQI is widely used and has been assessed for reliability and validity.In this study, improved sleep is a potential mediator of intervention effects, and a potentially important outcome on its own. The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.

Pittsburgh Sleep Quality Index (PSQI)

Body habitus is associated with many disease processes, and may be related to immune function and susceptibility to respiratory infection. Height will be assessed at baseline only. Weight will be measured at baseline, 1 and 4 months post-intervention, and at exit. Baseline BMI will be calculated and used as a covariate in statistical models. BMI will also be considered a secondary outcome of potential importance.

Body Mass Index (BMI)

Standard brachial blood pressure will be assessed by trained nurses using calibrated sphygmomanometers.

Blood Pressure

Laboratory-assessed objective measures will primarily serve to corroborate self-reports of disease severity. High sensitivity C-reactive protein (HS-CRP) is a well-established indicator of disease severity during respiratory infection, and can be measured in serum and in nasal wash.Concentrations of interleukin-6 (IL-6)and interleukin-8 (IL-8)in nasal wash have been shown to correlate with illness severity. More recently, interferon-gamma-induced protein 10 (IP-10) has been shown to be measurably increased in both serum and nasal wash during times of acute viral ARI. Biomarker levels were measured at the two standardized follow-up visits in December and March when participants were not ill.

Pro-Inflammatory Cytokines

Overall Study

Bruce Barrett MD PhD

Acute Respiratory Infection

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

common cold/sureau

Echinacea and Acute Respiratory Illness

University of Wisconsin Meditation & Exercise Cold Study

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