NCT01660737

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
4 years until next milestone

Results Posted

Study results publicly available

June 19, 2017

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

August 1, 2012

Results QC Date

April 21, 2016

Last Update Submit

March 9, 2021

Conditions

Hay Fever

Keywords

Hay feverPascallerg

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (10)

  • Numerical Rating Scale Well Beeing (Pre- Post)

    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)

    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)

    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)

    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)

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

  • +5 more secondary outcomes

Study Arms (1)

PASCALLERG® tablets in patients with hay fever

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

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients from natural practioners and doctors from Germany

You may qualify if:

  • hay fever

You may not qualify if:

  • Lactose intolerance and / or
  • Chromium hypersensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jennifer Lebert

Giessen, 35390, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25824400DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Jennifer Lebert
Organization
PASCOE Pharamzeutische Präparate GmbH
Jennifer.lebert@pascoe.de
0049+(0)641-7960-955

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2012

First Posted

August 9, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 30, 2021

Results First Posted

June 19, 2017

Record last verified: 2021-03

Locations

DE(1)