Multiple Physicians from Austria
Vienna, Etc., Austria
Location status: Recruiting
NCT Number: NCT06983847
The goal of this observational study is to learn more about the disease and the symptoms where the product will use and in which patient groups. Further on, it is interesting to know clinical pictures, the symptoms improve. Patients with acute or chronical disease with vitamin c deficiency could be involved.
The main questions it aims to answer are:
* how do the symptoms of the disease change * how is the tolerability
Interested in participating?
Request Info18 year–120 year
All sexes
Observational
Vienna, Etc., Austria
Location status: Recruiting
The aim of this long-term observational study is to document the use of Vitamin C Injektopas® 7.5g in patients with vitamin C deficiency. The deficiency condition can be diagnosed either by laboratory diagnosis or clinically, i.e. symptomatically on the basis of general vitamin C deficiency symptoms (e.g. weakness, fatigue, susceptibility to infections and psychological complaints such as depressive moods) through to more specific deficiency symptoms, which are primarily related to impaired collagen formation and therefore primarily affect connective tissue, blood vessels, cartilage and bones. These include, above all, haemorrhages in the skin, inflamed and bleeding gums - through to tooth loss, joint effusions, pain in the joints, bones and muscles as well as poorly healing wounds, etc.
The survey should be used to assess the disease underlying the vitamin C deficiency (the so-called underlying disease), the reduction in the symptoms of the disease under therapy and also the tolerability. Both acute and chronic underlying diseases should be taken into account.
In addition to the symptom enquiry, the global assessment of the efficacy and tolerability of therapy with Vitamin C Injektopas® 7.5g is evaluated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
The main aim was to measure the success of the treatment with Vitamin C-Injektopas® 7,5g by the documentation of the change in general and disease-specific symptoms.
The symptoms are measured by a score:
0 = not present, 1 = slightly, 2 = moderate and 3 = strong
The change of the symptoms is measured in change groups:
Time frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Global assessment of efficacy is measured by a score:
Time frame: Number of infusions through study completion, up to appr. 12 weeks
Number of infusions during the observational time
Time frame: on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Global Assessment of Tolerability of the treatment with Vitamin C-Injektopas® 7,5g
Global assessment of tolerability is measured by a score:
Time frame: therapy duration, an expected average of 12 weeks (for chronic diseases)
Quality of life in chronic disease, Numeric Scale (NRS) from 0 - 10
Contact information is provided by the study sponsor or research team.
Bianka B. Krick, CRA
CONTACT
Jennifer Brueckmann, CRA
CONTACT
Pascoe Pharmazeutische Praeparate GmbH
Industry
Observational Study on Vitamin C-Injektopas® 7.5g in Patients With Vitamin C Deficiency Due to Acute and Chronic Diseases
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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