Hay FeverNCT01660737
Observational Study With PASCALLERG ® in Patients With Hay Fever
An observational study of Hay Fever, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Hay Fever
- How many people
- 123 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Jul 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients from natural practioners and doctors from Germany
Who may be able to join
- hay fever
Who cannot join
- Lactose intolerance and / or
- Chromium hypersensitivity
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Hay Fever
- Keywords
- Hay fever, Pascallerg
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PASCALLERG® tablets in patients with hay fever | Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Pascallerg
Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)
Measured: 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)
Measured: app. 4 weeks after baseline (treatment app. for 4 weeks)
Secondary outcomes (10)
Numerical Rating Scale Well Beeing (Pre- Post)
Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence)
Measured: 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)
Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hay FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660737
- Sponsor's protocol ID
- 180A12PALL
- Status last verified
- Mar 2021
- First submitted
- 1 Aug 2012
- Last updated
- 30 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25824400
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study With PASCALLERG ® in Patients With Hay Fever
- ClinicalTrials.gov ID
- NCT01660737
- Acronym / sponsor ID
- 180A12PALL
- Conditions
- Hay Fever
- Keywords
- Hay fever, Pascallerg
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Posted 19 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PASCALLERG® tablets in patients with hay fever | – | –Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients from natural practioners and doctors from Germany
Key inclusion criteria (1 listed)
- hay fever
Key exclusion criteria (2 listed)
- Lactose intolerance and / or
- Chromium hypersensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of Pascallerg
Time frame: appr. 4 weeks after baseline (after appr. 4 weeks of treatment)
Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)
Tolerability of Pascallerg
Time frame: app. 4 weeks after baseline (treatment app. for 4 weeks)
Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)
10 secondary outcomes
Numerical Rating Scale Well Beeing (Pre- Post)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Change of Symptom Sneezing (Pre-post)
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Change of Symptom Rhinitis (Pre-post)
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Change of Symtom Fatigue / Tiredness
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Change of Symptom Headache (Pre-post)
Time frame: 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)
Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25824400Trompetter 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hay Fever, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Pascallerg (time frame: appr. 4 weeks after baseline (after appr. 4 weeks of treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01660737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.