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CompletedNCT01660737Updated Mar 30, 2021Results posted

Observational Study With PASCALLERG ® in Patients With Hay Fever

An observational study in Hay Fever, sponsored by Pascoe Pharmazeutische Praeparate GmbH. Completed at 1 site in Germany. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2021-03-30.

Sponsored by Pascoe Pharmazeutische Praeparate GmbH · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
123
Ages
1 Year and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hay Fever

Keywords

  • Hay fever
  • Pascallerg
03

In context

Rhinitis, Allergic, Seasonal

404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.

This study's enrollment of 123 is above the median of 86 across 32 observational studies indexed under Rhinitis, Allergic, Seasonal.

Browse Rhinitis, Allergic, Seasonal studies →

Lead sponsor

Pascoe Pharmazeutische Praeparate GmbH is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients from natural practioners and doctors from Germany

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • hay fever

Exclusion criteria

Exclusion Criteria:

  • Lactose intolerance and / or
  • Chromium
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
123 participants (actual)

Groups and cohorts

  • PASCALLERG® tablets in patients with hay fever

    Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.

06

What researchers measure

Primary outcomes

  1. Efficacy of Pascallerg

    Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)

    Time frame: appr. 4 weeks after baseline (after appr. 4 weeks of treatment)

  2. Tolerability of Pascallerg

    Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)

    Time frame: app. 4 weeks after baseline (treatment app. for 4 weeks)

Secondary outcomes

  1. Numerical Rating Scale Well Beeing (Pre- Post)

    Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

  2. Change of Symptom Dry Eyes (Pre- Post)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

  3. Change of Symptom Itching Eyes (Pre- Post)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

  4. Change of Symptom Burning Eyes (Pre-post)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

  5. Change of Symptom Bronchial Complaints (Pre-post)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

  6. Change of Symptom Sneezing (Pre-post)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

  7. Change of Symptom Rhinitis (Pre-post)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

  8. Change of Symtom Fatigue / Tiredness

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

  9. Change of Symptom Headache (Pre-post)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

  10. Change of Symptom Tearing Eyes (Pre-post)

    Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

    Time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)

07

Results

Posted Jun 19, 2017

Participant flow

Participant flow — Overall Study
MilestonePASCALLERG® Tablets in Patients With Hay Fever
Started123
Completed123
Not completed0

Outcome measures

PrimaryEfficacy of Pascallerg

Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)

Time frame:
appr. 4 weeks after baseline (after appr. 4 weeks of treatment)
Reported as:
Number · participants
Efficacy of Pascallerg
participantsPASCALLERG® Tablets in Patients With Hay Fever
Very good efficacy (symptoms complete decline)60
Good efficacy (symptoms clearly improved)44
Moderate efficacy (smptoms slightly improved)15
No efficacy (symptoms unchanged o worsend)2
No data available2
PrimaryTolerability of Pascallerg

Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)

Time frame:
app. 4 weeks after baseline (treatment app. for 4 weeks)
Reported as:
Number · participants
Tolerability of Pascallerg
participantsPASCALLERG® Tablets in Patients With Hay Fever
Very good122
Bad tolerability1
SecondaryNumerical Rating Scale Well Beeing (Pre- Post)

Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence)

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Reported as:
Number · participants
Numerical Rating Scale Well Beeing (Pre- Post)
participantsPASCALLERG® Tablets in Patients With Hay Fever
improved109
unchanged4
detoriorated2
SecondaryChange of Symptom Dry Eyes (Pre- Post)

Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Dry Eyes (Pre- Post)
participantsPASCALLERG® Tablets in Patients With Hay Fever
improved36
unchanged9
deteriorated0
SecondaryChange of Symptom Itching Eyes (Pre- Post)

Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Itching Eyes (Pre- Post)
participantsPASCALLERG® Tablets in Patients With Hay Fever
improved87
unchanged10
deteriorated4
SecondaryChange of Symptom Burning Eyes (Pre-post)

Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Burning Eyes (Pre-post)
participantsPASCALLERG® Tablets in Patients With Hay Fever
improved68
unchanged6
deteriorated2
SecondaryChange of Symptom Bronchial Complaints (Pre-post)

Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Bronchial Complaints (Pre-post)
participantsPASCALLERG® Tablets in Patients With Hay Fever
improved44
unchanged7
deterioreated3
SecondaryChange of Symptom Sneezing (Pre-post)

Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Sneezing (Pre-post)
participantsPASCALLERG® Tablets in Patients With Hay Fever
improved87
unchanged13
deteriorated7
SecondaryChange of Symptom Rhinitis (Pre-post)

Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Rhinitis (Pre-post)
participantsPASCALLERG® Tablets in Patients With Hay Fever
improved89
unchanged8
deteriorated5
SecondaryChange of Symtom Fatigue / Tiredness

Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Reported as:
Number · participants
Change of Symtom Fatigue / Tiredness
participantsPASCALLERG® Tablets in Patients With Hay Fever
improved77
unchanged11
deteriorated5
SecondaryChange of Symptom Headache (Pre-post)

Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Headache (Pre-post)
participantsPASCALLERG® Tablets in Patients With Hay Fever
improved38
unchanged15
deteriorated0
SecondaryChange of Symptom Tearing Eyes (Pre-post)

Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Tearing Eyes (Pre-post)
participantsPASCALLERG® Tablets in Patients With Hay Fever
improved70
unchanged7
deteriorated5

Adverse events

Collected over 4 weeks. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PASCALLERG® Tablets in Patients With Hay Fever—0/123 (0%)1/123 (0.8%)
Most frequent other events
Most frequent other events
EventPASCALLERG® Tablets in Patients With Hay Fever
rashSkin and subcutaneous tissue disorders1/123

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PASCALLERG® Tablets in Patients With Hay Fever
<=18 years30
Between 18 and 65 years84
>=65 years9
Age, Continuous
Age, Continuous(years)PASCALLERG® Tablets in Patients With Hay Fever
Mean36.00 ± 18.9
Sex: Female, Male
Sex: Female, Male(Participants)PASCALLERG® Tablets in Patients With Hay Fever
Female65
Male58
Region of Enrollment
Region of Enrollment(participants)PASCALLERG® Tablets in Patients With Hay Fever
Germany123
08

Study locations

1 site
  • Jennifer Lebert
    Gießen, 35390, Germany
09

References and documents

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 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2012, a primary completion of Jul 2013 and a completion of Jul 2013. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2017, 3 years 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2012
First posted
Aug 9, 2012
Start
Feb 2012
Primary completionActual
Jul 2013
CompletionActual
Jul 2013
Results first posted
Jun 19, 2017
Last update
Mar 30, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01660737
Lead sponsor
Pascoe Pharmazeutische Praeparate GmbH
Responsible party
Sponsor
First posted
Aug 9, 2012
Start date
Feb 2012
Primary completion
Jul 2013
Completion
Jul 2013
Results posted
Jun 19, 2017
Last update
Mar 30, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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