Virus Diseases168NCT00921934

Intravenous Vitamin C in the Treatment of Viral Infection, Especially in the Treatment of Shingles

An observational study of Virus Diseases and Herpes Zoster, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Chronic viral infections induce oxidative stress that can cause a number of concomitant diseases, e.g. cardio-vascular diseases or metabolic disorders. Therefore, a sufficient treatment of oxidative stress may be of benefit for the patient to prevent further diseases. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Virus Diseases, Herpes Zoster
How many people: 68 participants
Where: 1 siteGermany
Study dates: Apr 2009to Dec 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Study population: Cohort of adult patients suffering from acute viral infections, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany.

Due to the design of an Observational Cohort Study, no inclusion or exclusion criteria are named. The included patient group is described under "Cohort / Group".

Observational Criteria:

adult patients
acute viral infection (especially herpes zoster)
Primary Care patient
eligible for add-on therapy with vitamin C
willingness to provide pseudonymized data to the Sponsor

Trial locations and contacts

1 site in 1 country.

Germany1 site

Praxis Dr. Schencking, Rheinstr. 77a
Ransbach-Baumbach, Rhineland-Palatinate, 56235

Other trials in Germany

About this study

Official title: PASCORBIN 7.5g in the Treatment of Viral Infection, Especially Varicella Zoster Infection: An Observational Cohort Study

Shingles (herpes zoster infection) have been successfully treated with antioxidative substances like high-dose vitamin C for ages. Not only the acute symptoms can be diminished by high-dose vitamin C. Even long-term sequelae, like painful post-herpetic neuropathy, may be mitigated or even fully avoided.

Conditions: Virus Diseases, Herpes Zoster
Keywords: Herpes, Shingles, virus disease, vitamin C, ascorbic acid, antioxidant, oxidative stress
Medical subject headings: Virus Diseases, Herpes Zoster, Herpes Simplex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00921934
Study group	Role	What they receive
Vitamin C		Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of Pain Measured by VAS
VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS
Measured: visit 1 - 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Dec 2010

First posted17 Jun 2009 (estimated)
Study startApr 2009
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Virus DiseasesStudies 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: Prospective
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00921934
Sponsor's protocol ID: 168 A 08 VC
Acronym: 168
Status last verified: Nov 2017
First submitted: 16 Jun 2009
Last updated: 21 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care

All Virus Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PASCORBIN 7.5g in the Treatment of Viral Infection, Especially Varicella Zoster Infection: An Observational Cohort Study
ClinicalTrials.gov ID: NCT00921934
Acronym / sponsor ID: 168 / 168 A 08 VC
Conditions: Virus Diseases, Herpes Zoster
Keywords: Herpes, Shingles, virus disease, vitamin C, ascorbic acid, antioxidant, oxidative stress
Study type: Observational
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbHIndustry (pharma, biotech, devices)
Collaborators: Dr. Loges & Co. GmbH
Study start: Apr 2009
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 17 Jun 2009 (estimated)
Results: Posted 26 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Vitamin C	–	–Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Cohort of adult patients suffering from acute viral infections, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change of Pain Measured by VAS
Time frame: visit 1 - 3
VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS

Results and safety

Results posted to the registry on 26 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vitamin C	68	68

Primary outcome: Change of Pain Measured by VAS

Time frame: visit 1 - 3. Mean (Standard Deviation). Unit: pain intensity

Measure	Vitamin C n = 68
V1 (Baseline)	5.8 (2.4)
V2 (week 2)	2.2 (2.2)
V3 (week 12)	0.6 (1.1)
Last visit	1.2 (2.0)

Population analysed: Three patients had no pain at baseline (score value = 0) and were thus excluded from the statistical analysis. The descriptive results per visit are presented in the data below. V1 (Baseline) N=64, V2 (week 2)N=64, V3 (week 12)N= 47, Last vsit (N=64).

Adverse events

Time frame: 1.5 years. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vitamin C	0 of 68 (0%)	2 of 68 (2.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Virus Diseases

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care

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.

Martin Schencking, MD principal investigator

Rheinstr. 77a, D-56235 Ransbach-Baumbach

Bianka Krick study director

Pascoe Pharmazeutische Praeparate GmbH

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 Virus Diseases and Herpes Zoster, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 21 Dec 2017. 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 Germany. 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?

Yes. Results are posted in the registry (first posted 26 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change of Pain Measured by VAS (time frame: visit 1 - 3). 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 NCT00921934.

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 21 Dec 2017.