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chronic urticaria is one of the most common dermatological disease affecting many people, exploring most treatment options for its treatment is need of an hour.
Our study aim to compare the efficacy of Autologous Serum Therapy (AST) with levocetirizine in Chronic Urticaria patients
Urticaria is one of the most common skin diseases causing redness, and swelling in the dermis and epidermal layers and are severely pruritic.
Chronic urticaria is further sub-divided into chronic spontaneous urticaria and chronic inducible urticaria. International guidelines recommend non-sedating antihistamines once daily as first-line therapy for chronic spontaneous urticaria and chronic inducible urticaria.
Levocetirizine which is classified as a second-generation antihistamine and works by blocking histamine H1-receptors , is an effective treatment for CIU, characterized not only by a rapid and sustained response, but also by an important improvement in QOL.
Autologous serum therapy (AST) has been tried by many in patients with CAU with variable results, majority showing beneficial effects. AST has also been used in the treatment of ocular alkali burn patients Presence of tolerance generating anti-idiotype antibodies to mast cell degranulating antigens that induce remission of the disease forms the basis of AST and this therapy has been tried in various autoimmune diseases Our study aim to compare the efficacy of Autologous Serum Therapy (AST) with levocetirizine in Chronic Urticaria patients OBJECTIVE "TO COMPARE THE EFFICACY OF AUTOLOGOUS SERUM THERAPY VS LEVOCETRIZINE IN THE TREATMENT OF CHRONIC URTICARIA IN TERTIARY CARE HOSPITAL"
DATA COLLECTION:
Data will be collected on prescribed proforma which is attached, at Dermatology OPD, Sheikh Zayed Hospital, Rahim Yar Khan. Patient will be selected on basis of inclusion & exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will include 72 patients which will be divided into 2 groups, A & B, 36 in each group. Group A will receive AST, Group B will receive oral levocetirizine 5mg 1 tablet HS.
5 ml of blood will be collected and centrifuged at 3000 RPM for 10 min to obtain serum,2 ml of the serum will be injected into the gluteus muscle. We will give the patients 9 injections of Autologous Serum intramuscularly once a week .
Follow up visit will be after 2 months of last session.
DATA ANALYSIS:
Data will be analyzed by SPSS v25.0
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous serum therapy group | Active Comparator | Group A will receive AST 5 ml of blood will be collected and centrifuged at 3000 r.p.m for 10 min to obtain serum,2 ml of the serum will be injected into the gluteus muscle. We will give the patients injection of Autologous Serum intramuscularly once a week for 9weeks |
|
| levocetirizine group | Active Comparator | Group B will receive levocetirizine orally 5mg one tablet HS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous serum therapy | Drug | 5 ml of blood will be collected and centrifuged at 3000 r.p.m for 10 min to obtain serum,2 ml of the serum will be injected into the gluteus muscle. We will give the patients 9 injections of Autologous Serum intramuscularly once a week |
| Measure | Description | Time Frame |
|---|---|---|
| COMPARISON OF OUTCOME OF AUTOLOGOUS SERUM THERAPY VS LEVOCETRIZINE IN THE TREATMENT OF CHRONIC URTICARIA | Efficacy will be assessed clinically at each follow up visit. Final efficacy of each treatment will be determined at last follow up visit( i.e. at 7th week after start of treatment).The final efficacy will be divided into following groups on the basis of clinical resolution of disease: 1. Excellent efficacy: It is defined as greater than 80% reduction in the frequency of urticaria episodes per week as measured from baseline 2. moderate efficacy: It is defined as 50% to less than 80% reduction in number of urticaria episodes per week as measured from baseline healing of urticaria from the baseline. 3.non-efficaceos: It is defined as less than a 50% reduction in the frequency of urticaria episodes per week from baseline. | Clinical assessment for efficacy will be done monthly for 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Farah Humera, post graduate resident derma | Contact | +923328334251 | drfarahumera1@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheikh zayed Medical College and Hospital, Rahim Yar Khan, Punjab 644200 | Rahim Yar Khan | Punjab Province | 644200 | Pakistan |
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C472067 | levocetirizine |
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| Oral levocetirizine | Drug | Group B will receive oral levocetirizine 5mg 1 tablet HS. |
|
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |