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The aim of this observational study is to document the therapeutic use of PASCALLERG ® for hay fever. Based on the survey is a decrease in disease-specific symptoms when taking PASCALLERG ® over a period of 4 weeks will be documented. In addition to the compatibility can be assessed.
There are documented male and female patients over the age of one year who suffer from hay fever. The traetment time is about a period of 4 weeks with PASCALLERG® tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PASCALLERG® tablets in patients with hay fever | Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Pascallerg | Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy) | appr. 4 weeks after baseline (after appr. 4 weeks of treatment) |
| Tolerability of Pascallerg | Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability) | app. 4 weeks after baseline (treatment app. for 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale Well Beeing (Pre- Post) | Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence) | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
| Change of Symptom Dry Eyes (Pre- Post) |
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Inclusion Criteria:
Exclusion Criteria:
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patients from natural practioners and doctors from Germany
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jennifer Lebert | Giessen | 35390 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25824400 | Derived | Trompetter I, Lebert J, Weiss G. Homeopathic complex remedy in the treatment of allergic rhinitis: results of a prospective, multicenter observational study. Forsch Komplementmed. 2015;22(1):18-23. doi: 10.1159/000375244. Epub 2015 Feb 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PASCALLERG® Tablets in Patients With Hay Fever | Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PASCALLERG® Tablets in Patients With Hay Fever | Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Efficacy of Pascallerg | Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy) | Posted | Number | participants | appr. 4 weeks after baseline (after appr. 4 weeks of treatment) |
|
|
4 weeks
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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 | PASCALLERG® Tablets in Patients With Hay Fever | Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Lebert | PASCOE Pharamzeutische Präparate GmbH | 0049+(0)641-7960-955 | Jennifer.lebert@pascoe.de |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) |
| Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
| Change of Symptom Itching Eyes (Pre- Post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
| Change of Symptom Burning Eyes (Pre-post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
| Change of Symptom Bronchial Complaints (Pre-post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
| Change of Symptom Sneezing (Pre-post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
| Change of Symptom Rhinitis (Pre-post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
| Change of Symtom Fatigue / Tiredness | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
| Change of Symptom Headache (Pre-post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
| Change of Symptom Tearing Eyes (Pre-post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Tolerability of Pascallerg | Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability) | Posted | Number | participants | app. 4 weeks after baseline (treatment app. for 4 weeks) |
|
|
|
| Secondary | Numerical Rating Scale Well Beeing (Pre- Post) | Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence) | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Dry Eyes (Pre- Post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Itching Eyes (Pre- Post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Burning Eyes (Pre-post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Bronchial Complaints (Pre-post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Sneezing (Pre-post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Rhinitis (Pre-post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
|
|
|
| Secondary | Change of Symtom Fatigue / Tiredness | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Headache (Pre-post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
|
|
|
| Secondary | Change of Symptom Tearing Eyes (Pre-post) | Request Scale (0=not present, 1=mild, 2=moderate, 3=strong) | Posted | Number | participants | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline) |
|
|
|
| 0 |
| 123 |
| 1 |
| 123 |
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| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
|