Herpes Simplex InfectionsNCT02715752
A Retrospective Chart Review Study of Gene-Eden-VIR/Novirin
An observational study of Herpes Simplex Infections and Human Papillomavirus, run by The Center for the Biology of Chronic Disease at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Simplex Infections, Human Papillomavirus, Epstein-Barr Virus Infections
- What is being tested?
- Gene-Eden-VIR/Novirin
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Mar 2016
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women ages greater than 18 years old
Who may be able to join
- Latent viral infection with either HSV, HPV, VZV, EBV, or CMV
- Taking Gene-Eden-VIR/Novirin
Who cannot join
- Use of other antiviral treatments
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for the Biology of Chronic Disease
Valley Cottage, New York, 10989
About this study
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.
Read the detailed description
The medical community calls the movement from severe to mild disease and from mild to normal health, 'relieving symptoms', and the interventions that cause such movement, drugs, medications, or therapies. The alternative community calls the movement from normal health to superior health, 'boosting health' (or boosting the immune system, or improving your sex drive, or boosting any another well functioning physiological system), and the interventions that cause such movement, natural remedies, dietary supplements, complementary treatments, etc. In general, these interventions aim to achieve superior performance of a normal human body. Of course, boosting the body's normal performance improves many of its capabilities, such as higher resistance to diseases, faster recovery from fatigue, better mental concentration, etc. Each movement presents different objectives. Relieving symptoms represents the ability of an intervention to reduce the frequency, duration, and severity of a disease. In contrast, boosting health represents the ability of an intervention to increase the frequency, duration, and quality of a person's health. In the current study, the investigators would like to measure the changes in health-related complaints by analyzing charts of individuals, who are infected with latent virus, and who have used Gene-Eden-VIR/Novirin.
- Conditions
- Herpes Simplex Infections, Human Papillomavirus, Epstein-Barr Virus Infections, Varicella-zoster Virus Infection, Cytomegalovirus Infections
- Being tested
- Gene-Eden-VIR/Novirin
- Medical subject headings
- Herpes Simplex, Epstein-Barr Virus Infections, Varicella Zoster Virus Infection, Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene-Eden-VIR/NovirinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Herpes Simplex Virus Infection | Gene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months Receives: Dietary Supplement: Gene-Eden-VIR/Novirin | |
| Human Papillomavirus Infection | Gene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months Receives: Dietary Supplement: Gene-Eden-VIR/Novirin | |
| Epstein-Barr Virus Infection | Gene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months Receives: Dietary Supplement: Gene-Eden-VIR/Novirin | |
| Cytomegalovirus Infection | Gene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months Receives: Dietary Supplement: Gene-Eden-VIR/Novirin | |
| Varicella Zoster Virus Infection | Gene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months Receives: Dietary Supplement: Gene-Eden-VIR/Novirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of symptoms
Measured: one year
duration of symptoms
Measured: one year
Secondary outcomes (1)
time to first recurrence
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes Simplex InfectionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for the Biology of Chronic Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715752
- Sponsor's protocol ID
- 022015
- Status last verified
- Apr 2016
- First submitted
- 17 Mar 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27766602
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review Study of Gene-Eden-VIR/Novirin
- ClinicalTrials.gov ID
- NCT02715752
- Acronym / sponsor ID
- 022015
- Conditions
- Herpes Simplex Infections, Human Papillomavirus, Epstein-Barr Virus Infections, Varicella-zoster Virus Infection, Cytomegalovirus Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- The Center for the Biology of Chronic DiseaseUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Mar 2016 (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.
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.
Detailed description
The medical community calls the movement from severe to mild disease and from mild to normal health, 'relieving symptoms', and the interventions that cause such movement, drugs, medications, or therapies. The alternative community calls the movement from normal health to superior health, 'boosting health' (or boosting the immune system, or improving your sex drive, or boosting any another well functioning physiological system), and the interventions that cause such movement, natural remedies, dietary supplements, complementary treatments, etc. In general, these interventions aim to achieve superior performance of a normal human body. Of course, boosting the body's normal performance improves many of its capabilities, such as higher resistance to diseases, faster recovery from fatigue, better mental concentration, etc. Each movement presents different objectives. Relieving symptoms represents the ability of an intervention to reduce the frequency, duration, and severity of a disease. In contrast, boosting health represents the ability of an intervention to increase the frequency, duration, and quality of a person's health. In the current study, the investigators would like to measure the changes in health-related complaints by analyzing charts of individuals, who are infected with latent virus, and who have used Gene-Eden-VIR/Novirin.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Herpes Simplex Virus Infection | – | Dietary Supplement: Gene-Eden-VIR/NovirinGene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months |
| Human Papillomavirus Infection | – | Dietary Supplement: Gene-Eden-VIR/NovirinGene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months |
| Epstein-Barr Virus Infection | – | Dietary Supplement: Gene-Eden-VIR/NovirinGene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months |
| Cytomegalovirus Infection | – | Dietary Supplement: Gene-Eden-VIR/NovirinGene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months |
| Varicella Zoster Virus Infection | – | Dietary Supplement: Gene-Eden-VIR/NovirinGene-Eden-VIR/Novirin, oral, 1-4 capsules per day, 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women ages greater than 18 years old
Key inclusion criteria (2 listed)
- Latent viral infection with either HSV, HPV, VZV, EBV, or CMV
- Taking Gene-Eden-VIR/Novirin
Key exclusion criteria (1 listed)
- Use of other antiviral treatments
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 |
|---|---|---|
| Gene-Eden-VIR/Novirin | Dietary supplement | Cytomegalovirus Infection, Epstein-Barr Virus Infection, Herpes Simplex Virus Infection, Human Papillomavirus Infection, Varicella Zoster Virus Infection |
Primary outcome
frequency of symptoms
Time frame: one year
duration of symptoms
Time frame: one year
1 secondary outcome
time to first recurrence
Time frame: one year
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 26 Apr 2016.
- Derived from this study: PubMed 27766602Polansky 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Simplex Infections and Human Papillomavirus, run by The Center for the Biology of Chronic Disease 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 2 inclusion and 1 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 26 Apr 2016. 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. 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?
frequency of symptoms (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02715752, which also lists 1 linked publication.
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 26 Apr 2016.