HerpesPhase 1/2NCT01477879
Hsv 1 and 2 Gowey Protocol Versus Placebo
A Phase 1/2 study testing Versabase gel with sarracenia purpurea 20% liquid extract in people with Herpes, run by Naturopaths International at 1 site in United States.
Trial summary
This study will compare efficacy of versabase gel with 20% sarracenia purpurea versus placebo applied every 3-4 hours to herpes lesions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes
- What is being tested?
- Versabase gel with sarracenia purpurea 20% liquid extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2011
- Phase
- Phase 1/2
- 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
Who may be able to join
- Hsv 1\&2
Who cannot join
- No active lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Trial of Versabase/Sarracenia Purpurea Versus Placebo
This study will compare efficacy of versabase gel with 20% sarracenia purpurea versus placebo applied every 3-4 hours to herpes lesions.
Read the detailed description
Patients screened for hsv one or two. Patients with herpes given a 1/8 oz of gel. Researcher does not know which is active and which is placebo (placebo is actually just versabase gel). Patent applies gel to lesions every 3-4 hours. Returns to clinic on days 3, 5, and 14 for evaluation. Up to 50 patients may be enrolled.
- Conditions
- Herpes
- Being tested
- Versabase gel with sarracenia purpurea 20% liquid extract, placebo (versabase gel only)
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Versabase gel with sarracenia purpurea 20% liquid extractOther
Topical application of gel/plant mix to lesions
placebo (versabase gel only)Other
versabase gel only
| Study group | Role | What they receive |
|---|---|---|
| Versabase/20% S. purpurea extract | Active comparator | Not described Receives: Other: Versabase gel with sarracenia purpurea 20% liquid extract |
| placebo (versabase gel only) | Placebo comparator | placebo used will be versabase gel alone Receives: Other: placebo (versabase gel only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain scale-- subjective
Measured: 2 weeks
Size
Measure lesion size over 2 weeks
Measured: 2 weeks
Secondary outcomes (1)
Appearance
Photo taken of lesion w patient informed consent
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerpesStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naturopaths International
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Brandie Gowey, NMD, Naturopaths International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477879
- Sponsor's protocol ID
- HSV1&2
- Status last verified
- Nov 2011
- First submitted
- 15 Nov 2011
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Versabase/Sarracenia Purpurea Versus Placebo
- ClinicalTrials.gov ID
- NCT01477879
- Acronym / sponsor ID
- HSV1&2
- Conditions
- Herpes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Naturopaths InternationalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 Nov 2011 (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 will compare efficacy of versabase gel with 20% sarracenia purpurea versus placebo applied every 3-4 hours to herpes lesions.
Detailed description
Patients screened for hsv one or two. Patients with herpes given a 1/8 oz of gel. Researcher does not know which is active and which is placebo (placebo is actually just versabase gel). Patent applies gel to lesions every 3-4 hours. Returns to clinic on days 3, 5, and 14 for evaluation. Up to 50 patients may be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Versabase/20% S. purpurea extract | Active comparator | Other: Versabase gel with sarracenia purpurea 20% liquid extract |
| placebo (versabase gel only) | Placebo comparator | Other: placebo (versabase gel only)placebo used will be versabase gel alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hsv 1\&2
Key exclusion criteria (1 listed)
- No active lesions
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 |
|---|---|---|
| Versabase gel with sarracenia purpurea 20% liquid extractTopical application of gel/plant mix to lesions | Other | Versabase/20% S. purpurea extract |
| placebo (versabase gel only)versabase gel only | Other | placebo (versabase gel only) |
Primary outcome
Pain
Time frame: 2 weeks
Pain scale-- subjective
Size
Time frame: 2 weeks
Measure lesion size over 2 weeks
1 secondary outcome
Appearance
Time frame: 2 weeks
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 23 Nov 2011.
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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?
A Phase 1/2 study testing Versabase gel with sarracenia purpurea 20% liquid extract in people with Herpes, run by Naturopaths International 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 1 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 23 Nov 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain (time frame: 2 weeks). 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?
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 23 Nov 2011; AzTrials last refreshed its copy on 29 Oct 2026.