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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03163875
Other study ID # ziad
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 15, 2017
Last updated May 25, 2017
Start date June 1, 2017
Est. completion date August 1, 2018

Study information

Verified date May 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Urticaria is one of the most frequent presenting complaints in dermatology, allergy, and emergency departments. The term chronic urticaria (CU) is understood as the appearance of recurrent wheals more than twice a week for over 6 consecutive weeks .Urticaria is not a single disease but a reaction pattern that represents cutaneous mast cell degranulation, resulting in extravasation of plasma into the dermis. The incidence of chronic urticaria is unknown, but it is thought to occur in 0.1%-3% of the population


Description:

Chronic urticaria signs and symptoms include: patches of red or white wheals, usually on the face, trunk, arms or legs. Wheals vary in size, change shape, and appear and fade repeatedly as the reaction runs its course. Itching is common, which may be severe. Swelling may occur that causes pain or burning (angioedema), especially inside the throat and around the eyes, cheeks, lips, hands, feet and genitals.

It is characterized by a tendency for signs and symptoms to flare with triggers such as heat, exercise and stress as well as a tendency for symptoms to recur frequently and unpredictably, sometimes for months or years The significance of chronic urticaria is sometimes trivialised because it is a non-life-threatening disease, but the condition can be very uncomfortable and interfere with sleep and daily activities. It is one of the most common and frustrating diseases for both patients and physicians Chronic urticaria has a major impact on quality of life (QoL) , with impact on activities of daily living. Chronic urticaria patients reportedly suffer considerable loss of energy, sleep disturbance and emotional upset as well as restrictions in the social life. Depression and anxiety are the most common psychiatric diagnoses. These psychiatric disorders could also influence QoL


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date August 1, 2018
Est. primary completion date June 10, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

Patients with chronic urticaria defined as a 6-week or longer history of daily or almost daily itchy cutaneous weals with individual lesions lasting less than 24 h.

Age between 18 and 60 years.

Exclusion Criteria:

Patients who are unable to understand the questions, are unwilling to complete the questionnaire, or who have a psychiatric disorder, or obstructive sleep apnea.

Patients with malignant or central nervous system disease. Patients with cognitive impairment due to a current cerebral or psychotic illness.

Patients with current psychotherapy . glucocorticoids therapy in the last month.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hospital Anxiety and Depression Scale
To assess the levels of depression and anxiety, quality of sleep and quality of life (QoL) in chronic urticaria patients, using an interdisciplinary approach combining interview/questionnaire-based psychiatric and dermatological evaluations

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary measure number of patients affected with depression and anxity The levels of depression and anxiety will be assessed by Hospital Anxiety Depression Scale (HADS) . one year
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