Chronic Thrombocytopenic Purpura Clinical Trial
Official title:
Effect of Honey Bee Honey Intake on Children With Chronic Immune Thrombocytopenia
Based on the assumption that honey may have an immunomodulatory effect, the aim of our present study will be to verify whether the intake of honey, as a natural substance, in patients with chronic Immune Thrombocytopenia (ITP) could affect the platelet number and hence could affect the bleeding severity. Thirty patients suffering from chronic ITP will be recruited from the Hematology Clinic of the Pediatric Hospital of Ain Shams University, Cairo, Egypt. The diagnosis of ITP will be based on the presence of isolated thrombocytopenia with a peripheral blood platelet count less than 100 x 109/L, and absence of any obvious initiating and/or underlying cause of the thrombocytopenia. Chronic ITP is defined as ITP for at least 12 months. The age of the patients will range from 5 to 15 years, and they will be of both sexes. This study was approved by the local Ethics Committee of the Pediatric Department of Ain Shams University, and an informed consent to participate in this study will be obtained from at least one parent of each patient. Furthermore, an ascent form will be obtained from each patient above 7 years of age.
Study design:
A crossover design (two 12-weeks intervention periods) will be used to measure treatment
effects. The subjects will be randomized into two groups (intervention to control [I/C] and
control to intervention [C/I] groups). Each study group will have 15 subjects. The subjects
in the I/C group will consume 2 ml honey/kg/dose (maximum 50 ml/dose), twice weekly in the
first 12-week period (period 1) while the subjects in the C/I group will not receive honey as
a Control in period 1. After period 1 the subjects of each group will exchange their protocol
for the following 12-week period (period 2). This design will allow the treatment effects to
be measured between the study groups (namely between the different subjects) in the same
study period, or period 1, as well as in the same subjects in a crossover comparison of
periods 1 and 2.
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