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Study aim
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Evaluating the Impact of Thalidomide on Pain and Inflammation Reduction in Sickle Cell Disease Patients
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Design
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Thirty-two people are included in the study entirely randomly. The sampling method will be both before and after the intervention and fasting.
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Settings and conduct
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In a randomized clinical trial, 32 Sickle cell anemia patients with the study criteria were selected from those referred to Shahid Baghaei 2 Ahvaz Hospital in Khuzestan province. In adults, 100 mg thalidomide is taken with 80 mg aspirin at night at bedtime. Children will receive a dose of 2 to 5 mg thalidomide per kilogram along with 80 mg aspirin at bedtime for three months.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria will include sickle cell anemia patients who experience pain attacks and have healthy liver and kidney function. Patients with severe heart, liver, or kidney failure, pregnant women, those with a history of chemotherapy, or diabetic patients with inflammatory infections will be excluded. Additionally, patients who have taken anti-inflammatories within the last two months will not be eligible.
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Intervention groups
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Thirty-two sickle cell anemia patients will be selected based on the study’s inclusion criteria. Adult patients will take 100 mg of thalidomide and 80 mg of aspirin nightly. For children, the dose of thalidomide will range from 2 to 5 mg per kilogram, alongside 80 mg of aspirin. The treatment will last for three months, and levels of inflammatory factors, including IL-6 and TNF-α, will be measured both at the beginning and end of the study.
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Main outcome variables
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The primary outcomes include the average Visual Analog Scale for Pain (VAS) score and the concentrations of IL-6, TNF-α, and CRP. The ratio of neutrophils to lymphocytes (N/L) will also be determined.