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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01845051
Other study ID # CC-01
Secondary ID
Status Completed
Phase N/A
First received April 29, 2013
Last updated May 1, 2013
Start date November 2012
Est. completion date March 2013

Study information

Verified date May 2013
Source Baskent University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Baskent University

Outcome

Type Measure Description Time frame Safety issue
Other Inferior turbinate color and edema 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 No
Primary Specific Immunoglobulin E (IgE) 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 No
Primary Nasal Symptom Scores 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 No
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