Common ColdNCT01092039
Safety and Efficacy Study of Oral XIGO Tablets to Treat The Common Cold
A study testing lactoferrin, L-Glutamine and beta-glucans in people with Common Cold, run by Xigo Health LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold
- What is being tested?
- lactoferrin, L-Glutamine and beta-glucans
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: XIGO Effectiveness Study: An Investigation of the Safety and Efficacy of Oral XIGO Tablets on Patients Diagnosed With the Common Cold
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.
Read the 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.
- Conditions
- Common Cold
- Being tested
- lactoferrin, L-Glutamine and beta-glucans, Placebo Comparator
- Keywords
- Common Cold, Cold Virus, Feeling sick, Influenza
- Medical subject headings
- Common Cold, Nausea, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactoferrin, L-Glutamine and beta-glucansDietary supplement
Subject will be given XIGO pills or placebo. two tablets to be taken by mouth 3 times per day.
Placebo ComparatorDietary supplement
Subject will be given placebo comparator of two tablets to be taken by mouth 3 times per day.
| Study group | Role | What they receive |
|---|---|---|
| XIGO pill | Experimental | Oral Xigo tablet Receives: Dietary Supplement: lactoferrin, L-Glutamine and beta-glucans |
| Placebo | Placebo comparator | Oral placebo tablet Receives: Dietary Supplement: lactoferrin, L-Glutamine and beta-glucans; Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 days post dose
Secondary outcomes (3)
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.
Measured: Over 14 day observation period
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
Measured: 14 days post dose
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.
Measured: 14 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xigo Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gregory G Allen J.R., D.O., Principal investigator, NECCR/ IMCA LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092039
- Sponsor's protocol ID
- XIGO-001
- Status last verified
- Jun 2011
- First submitted
- 22 Mar 2010
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XIGO Effectiveness Study: An Investigation of the Safety and Efficacy of Oral XIGO Tablets on Patients Diagnosed With the Common Cold
- ClinicalTrials.gov ID
- NCT01092039
- Acronym / sponsor ID
- XIGO-001
- Conditions
- Common Cold
- Keywords
- Common Cold, Cold Virus, Feeling sick, Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Xigo Health LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XIGO pill | Experimental | Dietary Supplement: lactoferrin, L-Glutamine and beta-glucansOral Xigo tablet |
| Placebo | Placebo comparator | Dietary Supplement: lactoferrin, L-Glutamine and beta-glucans, Dietary Supplement: Placebo ComparatorOral placebo tablet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lactoferrin, L-Glutamine and beta-glucansSubject will be given XIGO pills or placebo. two tablets to be taken by mouth 3 times per day. | Dietary supplement | Placebo, XIGO pill |
| Placebo ComparatorSubject will be given placebo comparator of two tablets to be taken by mouth 3 times per day. | Dietary supplement | Placebo |
Primary outcome
Severity of cold symptoms over 7 days.
Time frame: 7 days post dose
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).
3 secondary outcomes
Severity of Cold Symptoms over 14 days
Time frame: Over 14 day observation period
Assess time to resolution
Time frame: 14 days post dose
Percentage of patients with unresolved symptoms
Time frame: 14 days post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory G Allen J.R., D.O. principal investigator
NECCR/ IMCA LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lactoferrin, L-Glutamine and beta-glucans in people with Common Cold, run by Xigo Health LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of cold symptoms over 7 days. (time frame: 7 days post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012.