NCT00921934

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 26, 2012

Completed
Last Updated

December 21, 2017

Status Verified

November 1, 2017

Enrollment Period

1.7 years

First QC Date

June 16, 2009

Results QC Date

August 1, 2012

Last Update Submit

November 23, 2017

Conditions

Keywords

HerpesShinglesvirus diseasevitamin Cascorbic acidantioxidantoxidative stress

Outcome Measures

Primary Outcomes (1)

  • Change of Pain Measured by VAS

    VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS

    visit 1 - 3

Study Arms (1)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Praxis Dr. Schencking, Rheinstr. 77a

Ransbach-Baumbach, Rhineland-Palatinate, 56235, Germany

Location

MeSH Terms

Conditions

Virus DiseasesHerpes ZosterHerpes Simplex

Condition Hierarchy (Ancestors)

InfectionsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. med. Martin Schencking
Organization
Department for Complementary and Alternative Medicine

Study Officials

  • Martin Schencking, MD

    Rheinstr. 77a, D-56235 Ransbach-Baumbach

    PRINCIPAL INVESTIGATOR
  • Bianka Krick

    Pascoe Pharmazeutische Praeparate GmbH

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 17, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 21, 2017

Results First Posted

October 26, 2012

Record last verified: 2017-11

Locations