Clinical trial NCT01092039: 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
Overall status: COMPLETED
Phase: NA
Conditions: Common Cold
Keywords: Common Cold
Cold Virus
Feeling sick
Influenza
Lead sponsor: Xigo Health LLC
Sponsor class: INDUSTRY
First posted: 2010-03-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Severity of cold symptoms over 7 days.
timeFrame: 7 days post dose
Secondary outcomes:
measure: Severity of Cold Symptoms over 14 days
timeFrame: Over 14 day observation period
measure: Assess time to resolution
timeFrame: 14 days post dose
measure: Percentage of patients with unresolved symptoms
timeFrame: 14 days post dose
Other outcomes:
Locations:
city: Fall River
country: United States
facility: Neccr/Imca Llc
state: Massachusetts
Study officials:
affiliation: NECCR/ IMCA LLC
name: Gregory G Allen J.R., D.O.
role: PRINCIPAL_INVESTIGATOR
References: