NCT02715752

Brief Summary

This study measured the changes in health-related complaints by analyzing charts of individuals, who are infected with a latent virus, who have used Gene-Eden-VIR/Novirin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

2 months

First QC Date

March 17, 2016

Last Update Submit

April 24, 2016

Conditions

Herpes Simplex InfectionsHuman PapillomavirusEpstein-Barr Virus InfectionsVaricella-zoster Virus InfectionCytomegalovirus Infections

Outcome Measures

Primary Outcomes (2)

  • frequency of symptoms

    one year

  • duration of symptoms

    one year

Secondary Outcomes (1)

  • time to first recurrence

    one year

Study Arms (5)

Herpes Simplex Virus Infection

Gene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months

Dietary Supplement: Gene-Eden-VIR/Novirin

Human Papillomavirus Infection

Gene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months

Dietary Supplement: Gene-Eden-VIR/Novirin

Epstein-Barr Virus Infection

Gene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months

Dietary Supplement: Gene-Eden-VIR/Novirin

Cytomegalovirus Infection

Gene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months

Dietary Supplement: Gene-Eden-VIR/Novirin

Varicella Zoster Virus Infection

Gene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months

Dietary Supplement: Gene-Eden-VIR/Novirin

Interventions

Gene-Eden-VIR/NovirinDIETARY_SUPPLEMENT
Cytomegalovirus InfectionEpstein-Barr Virus InfectionHerpes Simplex Virus InfectionHuman Papillomavirus InfectionVaricella Zoster Virus Infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men and women ages greater than 18 years old

You may qualify if:

  • Latent viral infection with either HSV, HPV, VZV, EBV, or CMV
  • Taking Gene-Eden-VIR/Novirin

You may not qualify if:

  • Use of other antiviral treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for the Biology of Chronic Disease

Valley Cottage, New York, 10989, United States

Location

Related Publications (1)

  • Polansky H, Itzkovitz E, Javaherian A. Clinical study of Gene-Eden-VIR/Novirin in genital herpes: suppressive treatment safely decreases the duration of outbreaks in both severe and mild cases. Clin Transl Med. 2016 Dec;5(1):40. doi: 10.1186/s40169-016-0121-6. Epub 2016 Oct 20.

    PMID: 27766602DERIVED

MeSH Terms

Conditions

Herpes SimplexEpstein-Barr Virus InfectionsVaricella Zoster Virus InfectionCytomegalovirus Infections

Interventions

Gene-Eden-VIR

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesTumor Virus Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 22, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 26, 2016

Record last verified: 2016-04

Locations

US(1)