Back to resultsSafety and Efficacy Study of Oral XIGO Tablets to Treat The Common Cold
Primary Purpose
Common Cold
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lactoferrin, L-Glutamine and beta-glucans
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold focused on measuring Common Cold, Cold Virus, Feeling sick, Influenza
Eligibility Criteria
Inclusion Criteria:
- Must be in good health in the clinical judgment of the investigator, other than cold symptoms
- Must have a cumulative score of 2 or higher, but not larger than 6, with symptom severity rated as 0=absent, 1=mild, 2= moderate, or 3=severe for each of the eight symptoms: sneezing, nasal discharge, nasal obstruction, sore throat, cough, headache, malaise and chillness. At least one of the first four "cold specific" symptoms must be present, and none of these symptoms can have been present for more than 12 hours.
- Must enter trial within 12 hours of symptoms onset.
- Aged 18-50 years, (inclusive), at visit 1.
- Subjects must understand and sign and date an informed consent form prior to any study related procedures being performed.
- Subjects must be capable of understanding and following directions.
Exclusion Criteria:
- Subjects taking medications, other than birth control, which, in the opinion of the investigator, could influence the purpose, integrity or outcome of the trial.
- Pre-menopausal women (last menstruation <=1 year prior to ICF) who are nursing or pregnant or are of child-bearing potential and, in the opinion of the investigator, are not practicing an acceptable method of birth control, or do not plan to continue using method throughout the study.
- A history of adverse reactions to OTC drugs or other personal care products.
- Subjects who have used systemic steroids for at least 6 weeks prior to trial initiation or during the trial.
- A medical history of autoimmune disease, including Type 1 or Type 2 diabetes or HIV.
- Treatment with immunosuppressive drugs with the exception of cyclosporine for keratitis sicca.
Sites / Locations
- Neccr/Imca Llc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
XIGO pill
Placebo
Arm Description
Oral Xigo tablet
Oral placebo tablet
Outcomes
Primary Outcome Measures
Severity of cold symptoms over 7 days.
The primary outcome measure will be to assess the severity of the typical interrelated common cold symptoms, over the first seven days of observation period, with the first day being the 24 hour period after first dose of treatment, using the patient/subject completion of the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21).
Secondary Outcome Measures
Severity of Cold Symptoms over 14 days
The secondary outcome measures will be to assess the severity of the typical interrelated common cold symptoms, over the fourteen days of observation period, with the first day being 24 hours after first dose of treatment, using the patient/subject completion of the WURSS-21.
Assess time to resolution
This secondary outcome is to assess the time to resolution of the typical interrelated common cold symptoms, with resolution deemed to occur when participant reports being "not sick" for two days in a row
Percentage of patients with unresolved symptoms
This secondary outcome is to assess the % of patients with clinically unresolved symptoms at day 14, as accessed by the attending investigator. This will include secondary complications such as rhinitis, sinusitis, lower respiratory tract infections and asthma exacerbations.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01092039
Brief Title
Safety and Efficacy Study of Oral XIGO Tablets to Treat The Common Cold
Official Title
XIGO Effectiveness Study: An Investigation of the Safety and Efficacy of Oral XIGO Tablets on Patients Diagnosed With the Common Cold
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Xigo Health LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study will be to assess the efficacy and safety of XIGO administered orally, three times a day, compared with placebo in patients with the common cold.
Detailed Description
The common cold is one of the most frequent human illnesses and has been shown to result in significant morbidity and economic loss. At the present time no truly effective therapy is available. Therapeutic interventions with compounds such as zinc have been found to be helpful however well reported side-effects have prevented its extensive use.
Based on several years of anecdotal clinical evidence which has shown that XIGO is effective in alleviating the symptoms of the common cold-the findings of which are supported by competent and reliable evidence from in vivo and in vitro and clinical trials studies on each of the individual active ingredients of the formulation, it has been proposed that XIGO, when administered orally, has a direct stimulatory effect on multiple components of the immune system. It is proposed that this stimulation increases both the immune cell population as well as its functionality and this will be observed in cells and molecules from both the innate and adaptive responses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
Common Cold, Cold Virus, Feeling sick, Influenza
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
XIGO pill
Arm Type
Experimental
Arm Description
Oral Xigo tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo tablet
Intervention Type
Dietary Supplement
Intervention Name(s)
lactoferrin, L-Glutamine and beta-glucans
Intervention Description
Subject will be given XIGO pills or placebo. two tablets to be taken by mouth 3 times per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Comparator
Intervention Description
Subject will be given placebo comparator of two tablets to be taken by mouth 3 times per day.
Primary Outcome Measure Information:
Title
Severity of cold symptoms over 7 days.
Description
The primary outcome measure will be to assess the severity of the typical interrelated common cold symptoms, over the first seven days of observation period, with the first day being the 24 hour period after first dose of treatment, using the patient/subject completion of the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21).
Time Frame
7 days post dose
Secondary Outcome Measure Information:
Title
Severity of Cold Symptoms over 14 days
Description
The secondary outcome measures will be to assess the severity of the typical interrelated common cold symptoms, over the fourteen days of observation period, with the first day being 24 hours after first dose of treatment, using the patient/subject completion of the WURSS-21.
Time Frame
Over 14 day observation period
Title
Assess time to resolution
Description
This secondary outcome is to assess the time to resolution of the typical interrelated common cold symptoms, with resolution deemed to occur when participant reports being "not sick" for two days in a row
Time Frame
14 days post dose
Title
Percentage of patients with unresolved symptoms
Description
This secondary outcome is to assess the % of patients with clinically unresolved symptoms at day 14, as accessed by the attending investigator. This will include secondary complications such as rhinitis, sinusitis, lower respiratory tract infections and asthma exacerbations.
Time Frame
14 days post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be in good health in the clinical judgment of the investigator, other than cold symptoms
Must have a cumulative score of 2 or higher, but not larger than 6, with symptom severity rated as 0=absent, 1=mild, 2= moderate, or 3=severe for each of the eight symptoms: sneezing, nasal discharge, nasal obstruction, sore throat, cough, headache, malaise and chillness. At least one of the first four "cold specific" symptoms must be present, and none of these symptoms can have been present for more than 12 hours.
Must enter trial within 12 hours of symptoms onset.
Aged 18-50 years, (inclusive), at visit 1.
Subjects must understand and sign and date an informed consent form prior to any study related procedures being performed.
Subjects must be capable of understanding and following directions.
Exclusion Criteria:
Subjects taking medications, other than birth control, which, in the opinion of the investigator, could influence the purpose, integrity or outcome of the trial.
Pre-menopausal women (last menstruation <=1 year prior to ICF) who are nursing or pregnant or are of child-bearing potential and, in the opinion of the investigator, are not practicing an acceptable method of birth control, or do not plan to continue using method throughout the study.
A history of adverse reactions to OTC drugs or other personal care products.
Subjects who have used systemic steroids for at least 6 weeks prior to trial initiation or during the trial.
A medical history of autoimmune disease, including Type 1 or Type 2 diabetes or HIV.
Treatment with immunosuppressive drugs with the exception of cyclosporine for keratitis sicca.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory G Allen J.R., D.O.
Organizational Affiliation
NECCR/ IMCA LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neccr/Imca Llc
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
12. IPD Sharing Statement
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Safety and Efficacy Study of Oral XIGO Tablets to Treat The Common Cold
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