Clinical Trial: Safety and Efficacy Study of Oral XIGO Tablets to Treat The Common Cold

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: XIGO Effectiveness Study: An Investigation of the Safety and Efficacy of Oral XIGO Tablets on Patients Diagnosed With the Common Cold

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 Summary:

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.


Sponsor: Xigo Health LLC

Current 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Severity of Cold Symptoms over 14 days [ Time Frame: Over 14 day observation period ]
    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 [ Time Frame: 14 days post dose ]
    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 [ Time Frame: 14 days post dose ]
    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.


Original Secondary Outcome: Same as current

Information By: Xigo Health LLC

Dates:
Date Received: March 22, 2010
Date Started: March 2010
Date Completion:
Last Updated: July 23, 2012
Last Verified: June 2011