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| Name | Class |
|---|---|
| Dr. Loges & Co. GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of Pain Measured by VAS | VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS | visit 1 - 3 |
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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:
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Cohort of adult patients suffering from acute viral infections, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Martin Schencking, MD | Rheinstr. 77a, D-56235 Ransbach-Baumbach | Principal Investigator |
| Bianka Krick | Pascoe Pharmazeutische Praeparate GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis Dr. Schencking, Rheinstr. 77a | Ransbach-Baumbach | Rhineland-Palatinate | 56235 | Germany |
Between April 2009 and December 2010 16 general practitioners recorded data of 68 participants with symptomatic herpes zoster (one patient with viral infection) who received vitamin C intravenously (Pascorbin® 7.5 g/50 ml) for approximately 2 weeks in addition to standard treatment.
The patients were recruited from general practioners between April 2009 and December 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Pain Measured by VAS | VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS | 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). | Posted | Mean | Standard Deviation | pain intensity | visit 1 - 3 |
|
1.5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensation of heat on the injection site | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. med. Martin Schencking | Department for Complementary and Alternative Medicine | +0049-2602-684-614 |
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D006562 | Herpes Zoster |
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
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| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Weihgt, kg | Mean | Standard Deviation | kg |
|
| Concomitant immunosuppressive disease | Immunosuppressive conditions = malignant neoformation of the mammae, diabetes mellitus, bronchial asthma, neurodermatitis, malignant neoformation, chemotherapy, breast ablation, hyperthyreosis, B-cell lymphoma, laryngeal cancer, pernicious anaemia, hepatitis, non-Hodgkin lymphoma, immunoglobulin-G deficiency, pneumoconiosis. | Number | participants |
|
| Duration of Herpes Zoster-specific complaints (separated into groups) | Number | participants |
|
| Number of concomitant medications for the inclusion diagnosis | Number | participants |
|
| Common symptoms at baseline gerneral fatigue | Number | participants |
|
| Common symptoms at baseline impaired concentration | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 68 |
| 2 |
| 68 |
| numbness sensation up to the fingertips | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| burning | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Urticarial drug inducted exanthema on truncus | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Urticarial drug inducted exanthema on torso | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| protracted diarrhoe | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
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| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |