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

This study has been completed.
Sponsor:
Information provided by:
Xigo Health LLC
ClinicalTrials.gov Identifier:
NCT01092039
First received: March 22, 2010
Last updated: July 23, 2012
Last verified: June 2011
  Purpose

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.


Condition Intervention
Common Cold
Dietary Supplement: lactoferrin, L-Glutamine and beta-glucans
Dietary Supplement: Placebo Comparator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: XIGO Effectiveness Study: An Investigation of the Safety and Efficacy of Oral XIGO Tablets on Patients Diagnosed With the Common Cold

Resource links provided by NLM:


Further study details as provided by Xigo Health LLC:

Primary Outcome Measures:
  • Severity of cold symptoms over 7 days. [ Time Frame: 7 days post dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over 14 day observation period ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 140
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XIGO pill
Oral Xigo tablet
Dietary Supplement: lactoferrin, L-Glutamine and beta-glucans
Subject will be given XIGO pills or placebo. two tablets to be taken by mouth 3 times per day.
Placebo Comparator: Placebo
Oral placebo tablet
Dietary Supplement: lactoferrin, L-Glutamine and beta-glucans
Subject will be given XIGO pills or placebo. two tablets to be taken by mouth 3 times per day.
Dietary Supplement: Placebo Comparator
Subject will be given placebo comparator of two tablets to be taken by mouth 3 times per day.

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092039

Locations
United States, Massachusetts
Neccr/Imca Llc
Fall River, Massachusetts, United States, 02720
Sponsors and Collaborators
Xigo Health LLC
Investigators
Principal Investigator: Gregory G Allen J.R., D.O. NECCR/ IMCA LLC
  More Information

No publications provided

Responsible Party: Rudy Beeck, CEO, XIGO Health, LLC
ClinicalTrials.gov Identifier: NCT01092039     History of Changes
Other Study ID Numbers: XIGO-001
Study First Received: March 22, 2010
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Xigo Health LLC:
Common Cold
Cold Virus
Feeling sick
Influenza

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014