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

This study has been completed.
Sponsor:
Collaborator:
Dr. Loges & Co. GmbH
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT00921934
First received: June 16, 2009
Last updated: September 25, 2012
Last verified: August 2012
  Purpose

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
Virus Diseases
Herpes Zoster

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pascoe Pharmazeutische Praeparate GmbH:

Primary Outcome Measures:
  • Change of Pain Measured by VAS [ Time Frame: visit 1 - 3 ] [ Designated as safety issue: No ]
    VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS


Enrollment: 68
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT00921934     History of Changes
Other Study ID Numbers: 168 A 08 VC
Study First Received: June 16, 2009
Results First Received: August 1, 2012
Last Updated: September 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on October 02, 2014