Azathioprine Versus Corticosteroids in Parthenium Dermatitis
Palabras clave
Abstracto
Descripción
Detailed research plan Clinical evaluation About 60 clinically diagnosed adult patients having Parthenium dermatitis will be taken up for the study. Pregnant females and lactating mothers will be excluded. All the patients will be patch tested with the standardised aqueous extract of Parthenium hysterophorus to confirm the diagnosis and those showing positive patch test reactions to standardised extract will be tested further with serial dilutions of the antigens to determine the titre of contact hypersensitivity (TCH).20 Antibodies do not have any role in this disease therefore the estimation of immunoglobulins will not be done. The diagnosis will be done by patch test. It will be a randomised, clinically study where the patients will be randomly treated with azathioprine 300 mg per week or azathioprine 100 mg a day orally along with topical clobetasol propionate 0.05% w/w and oral cetirizine hydrochloride 10 mg daily for symptomatic relief. No other drugs including the medicines of alternate system will be given for the dermatitis. Clinical evaluation of the patients will be undertaken every four weeks. This will be continued for six months. After 6 months the treatment will be stopped and the patients will be followed up for another 6 months. The graphic record of the disease activity and the treatment will be maintained. In addition, each patient will be evaluated for the side effects of these regimens clinically as well as by the laboratory parameters as per the proforma enclosed, especially haemoglobin, total blood count, differential count, platelets, serum bilirubin, serum alkaline phosphate, serum transaminases, serum electrolytes, serum creatinine, blood urea, blood sugar, urine routine and microscopy and stool examination for occult blood. These tests will be carried out before starting the therapy and then repeated every month during the follow up period. Chest X-ray electrocardiogram and TCH will also be done before the therapy and then at six months unless otherwise required. At the end of the study period, a final evaluation based on the change in severity of the dermatitis, changes in the titre of contact hypersensitivity and the side effects of the drugs will be made. Statistical analysis using chi-square test will be done.
fechas
Verificado por última vez: | 04/30/2008 |
Primero enviado: | 09/11/2005 |
Inscripción estimada enviada: | 09/11/2005 |
Publicado por primera vez: | 09/18/2005 |
Última actualización enviada: | 05/05/2008 |
Última actualización publicada: | 05/07/2008 |
Fecha de inicio real del estudio: | 01/31/2003 |
Fecha estimada de finalización primaria: | 09/30/2005 |
Fecha estimada de finalización del estudio: | 12/31/2005 |
Condición o enfermedad
Intervención / tratamiento
Drug: azathioprine and corticosteroids for Parthenium dermatitis
Fase
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - All adult patients having ABCD, as shown by the clinical manifestations and positive patch tests with Parthenium, who are willing to participate in the study. Exclusion Criteria: - Patients below the age of 18 years - Pregnant and lactating women. - Patients whose baseline investigations reveal hematological abnormalities or abnormalities of liver or renal function. |
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Medidas de resultado primarias
1. Clinical remission and side effects [undefined]
Medidas de resultado secundarias
1. Duration of remission [undefined]