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Intravenous Vitamin C in the Treatment of Viral Infection, Especially in the Treatment of Shingles (168)

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ClinicalTrials.gov Identifier: NCT00921934
Recruitment Status : Completed
First Posted : June 17, 2009
Results First Posted : October 26, 2012
Last Update Posted : December 21, 2017
Sponsor:
Collaborator:
Dr. Loges & Co. GmbH
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

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.


Condition or disease
Virus Diseases Herpes Zoster

Study Design
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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PASCORBIN 7.5g in the Treatment of Viral Infection, Especially Varicella Zoster Infection: An Observational Cohort Study
Study Start Date : April 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles Vitamin C
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921934


Locations
Germany
Praxis Dr. Schencking, Rheinstr. 77a
Ransbach-Baumbach, Rheinland-Pfalz, Germany, 56235
Sponsors and Collaborators
Pascoe Pharmazeutische Praeparate GmbH
Dr. Loges & Co. GmbH
Investigators
Principal Investigator: Martin Schencking, MD Rheinstr. 77a, D-56235 Ransbach-Baumbach
Study Director: Bianka Krick Pascoe Pharmazeutische Praeparate GmbH
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT00921934     History of Changes
Other Study ID Numbers: 168 A 08 VC
First Posted: June 17, 2009    Key Record Dates
Results First Posted: October 26, 2012
Last Update Posted: December 21, 2017
Last Verified: November 2017

Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:
Herpes
Shingles
virus disease
vitamin C
 ascorbic acid
antioxidant
oxidative stress

Additional relevant MeSH terms:
Herpes Zoster
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Vitamins
Ascorbic Acid
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents