- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01845051
Is There a Comorbidity Between Migraine and Allergic Rhinitis?
May 1, 2013 updated by: Işıl Adadan Güvenç, Baskent University
The researchers investigated the relationship between migraine and allergy.
For this purpose, the researchers designed a controlled study to evaluate nasal symptoms and signs; and to perform Specific Immunoglobulin E (IgE) measurements in migraine patients and healthy subjects.
According to these results the prevalence of allergic rhinitis in migraine group was planned to be compared to that of the healthy controls, statistically.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
80
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Migraine patients attending neurology clinic and healthy subjects
Description
Inclusion Criteria:
- patients with migraine
Exclusion Criteria:
- other neurologic disorders that may contribute to headaches, such as stroke, cerebral palsy, trigeminal neuralgia, and seizure disorder
- also acute and chronic sinusitis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Migraine group
Patients diagnosed with migraine
|
Healthy group
Healthy subjects with no migraine as control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specific Immunoglobulin E (IgE)
Time Frame: 1 day
|
Blood samples were taken from study and control group for the determination of Specific IgE panel against six different allergens: (1) fungi, (2) grass pollens, (3) tree pollens, (4) wild herbs, (5) mite 1, (6) mite 2. For all of specific IgE panels, <0,7 RU/ml was negative; and >0,7 RU/ml was Positive.
|
1 day
|
Nasal Symptom Scores
Time Frame: 1 day
|
Symptoms were assessed with a questionnaire for the presence and severity of allergic rhinitis (AR) symptoms on a scale of 0-3 (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Symptoms of AR (Nasal discharge, nasal congestion, itching and sneezing) were graded between 0-3.
|
1 day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
İnferior turbinate color and edema
Time Frame: 1 day
|
inferior concha colour (0=natural, 1=pale, 2=bluish and 3=severely pale or bluish) and turbinate edema were assessed during ENT examination on 0-3 scale (0 = no, 1 = mild, 2 = moderate, 3 = severe).
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
April 29, 2013
First Submitted That Met QC Criteria
May 1, 2013
First Posted (Estimate)
May 3, 2013
Study Record Updates
Last Update Posted (Estimate)
May 3, 2013
Last Update Submitted That Met QC Criteria
May 1, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Headache Disorders, Primary
- Headache Disorders
- Rhinitis
- Rhinitis, Allergic
- Migraine Disorders
Other Study ID Numbers
- CC-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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