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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05992987
Other study ID # Soh-Med-23-07-12MS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 15, 2023
Est. completion date March 31, 2024

Study information

Verified date July 2023
Source Sohag University
Contact Ahmed M Ahmed, M.B.B.Ch
Phone +201093593974
Email Dr.ahmed.elsheikh94@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

adenosine deaminase activity (ADA) has been reported to be elevated in various diseases such as psoriasis, acne and juvenile idiopathic arthritis. There is no previous studies that assessed ADA in chronic spontaneous urticaria (CSU) .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date March 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult patients complaining of CSU and a group of age and sex-matched healthy controls (blood donors). Exclusion Criteria: - Pregnancy and lactation. - Patients with systemic diseases, especially those with autoimmune diseases and infections. - Patients with skin diseases. - Patients on medications such as antibiotics, nonsteroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, anticonvulsants, penicillin, and combined oral contraceptives.

Study Design


Intervention

Diagnostic Test:
Adenosine deaminase serum level
Adenosine deaminase will be measured by enzymatic (clorometric / kinetic) method (Diazyme laboratories, San Diego, California, USA).
IgE antibodies serum level
Level of IgE will be measured by electrochemiluminesence immunoassay (ECLIA, automatic cobase immunoassay, Roche Diagnostics GmbH, Mannheim, USA).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Outcome

Type Measure Description Time frame Safety issue
Primary Serum level of adenosine deaminase Difference in serum level of adenosine deaminase between CSU group and control group 3 months
Primary Serum level of IgE Difference in serum level of IgE between CSU group and control group 3 months
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